近日，EDQM正式发布欧洲药典第12版，这是首版仅提供在线版本的欧洲药典，从本版欧洲药典开始，欧洲药典将仅提供在线版本，在线版欧洲药典内容包含现行、待实施和某些以前的欧洲药典版本，并支持强大的搜索工具、信息中心和新的筛选工具和属性无缝地检索到他们需要的内容。第11 版的所有用户在过渡期内仍然保持有效，直到2025 年底。自2026 年1 月1 日起，用户将只能订阅在线版本。

 

EP12的新特性

在线访问

从第EP12.1开始，欧洲药典将完全在线提供，所有文本都可在改进的、用户友好的平台上供订阅者使用。会用一种更直观的方法，更现代化的界面，快速高效地访问所需的内容，具有更强的搜索功能、高效的仪表板、新的筛选功能和属性等等。

全新的构成

新的版本由三卷组成（编号12.1-12.3），对应2025年欧洲药典委员会会议在其中通过的新文本和修订文本，将取代以前三年一个版本，八个增补的更新周期。

此外，将引入365天的许可模式，简化许可管理。欧洲药典将过渡到新的平台和出版模式，以便顺利进行这些更改。

所有第11版的订阅将在过渡期内有效，直至2025年底。

自2026年1月1日起，仅新平台可用。

全新的功能

新的欧洲药典平台功能包括：

可访问所有现行有效文本以及自第11.0卷以来出版的文本；

文本状态指示灯系统（绿色表示“有效”，橙色表示“尚未生效”，红色表示“不再生效”）；

文本内嵌菜单，方便在不同版本之间导航；

改进的筛选功能、预定义搜索和更新的结果显示；

访问档案和知识数据库中的补充信息。

全新欧洲药典365 天许可证提供一年的欧洲药典在线平台访问权限，自许可证密钥(EPID) 激活之日起生效。 功能包括：

显示许可证剩余席位数量和剩余天数的计数器；

许可证续订选项，并自动重新分配用户访问权限；

到期前自动发送电子邮件提醒。

欧洲药典网站提供英语和法语双语版本，兼容最新版本的Chrome、Edge、Firefox 和Safari浏览器。

 

 

本版欧洲药典发布的新文本、修订和校正内容如下：

Brief descriptions of the modifications that have been made to new, revised and corrected texts adopted by the European Pharmacopoeia Commission at the November session and published in Issue 12.1 are provided below. Please note that these descriptions are not provided systematically for new and corrected texts, but are instead provided on a case - by - case basis. This information is reproduced in the knowledge database under View history.

对在欧洲药典委员会11 月会议上通过并在第12.1 期发布的新文本、修订文本和校正文本所做修改的简要说明。请注意，这些描述并非系统地针对新文本和校正文本提供，而是根据具体情况提供。此信息复制自知识数据库的 “查看历史记录” 视图。
All revised, corrected or deleted parts of a text published in the European Pharmacopoeia are indicated by change marks in the form of triangles.

已发布在《欧洲药典》中的文本的所有修订、校正或删除部分均以三角形形式的变更标记指示。
GENERAL CHAPTERS

通论章节
1. General notices

1. 总则
As a result of the transition of the European Pharmacopoeia to a solely online format from the 12th Edition, several changes to the way in which information about texts is displayed have been introduced in order to improve the user experience. Linked to this, the General Notices has undergone a minor revision to update the information about the organisation of the publication cycle and the general monographs.

由于《欧洲药典》从第12 版起转为仅在线形式，为改进用户查看文本信息的方式，进行了几处更改。与此相关的是，《通则》进行了小幅修订，以更新有关出版物周期和通论的信息。

1.1.1 General Principles: wording "edition or supplement" replaced by "issue" to reflect the terminology used to describe the new publication cycle where each edition is composed of three "issues".

1.1.1 一般原则：“版本或增刊” 的表述被 “期” 取代，以反映用于描述每个版本所包含的三个 “期” 的新出版周期术语。
1.4 General monographs and general monographs on dosage forms: section1.4 of the General Notices has been revised to define more clearly which monographs are considered "general monographs" and to improve the overall clarity of the section.

1.4 通论和剂型通论：《总则》的1.4 节已修订，以更明确地界定哪些专论被视为 “通论”，并提高该节的整体清晰度。

Separate to the changes driven by the new European Pharmacopoeia format, the following modification has also been made.

此外，为推动《欧洲药典》格式的更新，还进行了以下修改：
1.1.2.6 Pharmacopoeial harmonisation: wording revised to indicate that the Pharmacopoeial Discussion Group (PDG) has more than 3 members.

1.1.2.6 药典协调：措辞修订，以表明药典讨论小组(PDG) 有超过3 名成员。
2.2.39. Molecular mass distribution in dextrans

2.2.39.  葡聚糖中的分子量分布
System suitability: criteria revised from fixed ranges to relative ranges around the assigned value of the N - CRSs; CRSs used in system suitability replaced in line with revised criteria.

系统适用性：标准从固定范围修订为围绕指定N - CRSs 值的相对范围；用于系统适用性的N - CRSs 已被修订标准取代。
2.5.42. N - Nitrosamines in active substances and medicinal products

2.5.42.  活性物质和药品中的N-亚硝胺
Inclusion of sartan - containing medicinal products in the scope of procedures A and C, and procedure A can be applied as a quantitative test. Addition of the requirement for performing a validation when a procedure is modified beyond the allowable adjustments of chromatographic conditions listed in Chromatographic separation techniques (2.2.46).

将含沙坦的药品纳入程序A 和C 的范围，程序A 可用作定量测试。当程序在允许的调整范围之外修改时，增加了进行验证的要求，色谱条件见 “色谱分离技术”(2.2.46)。
2.9.34. Bulk density of powders

2.9.34. 粉末的堆密度
This minor revision corresponds to Revision 4, Correction 2 (based on the Pharmacopoeial Discussion Group (PDG) working procedure) within the Pharmacopoeial harmonisation process. The coordinating pharmacopoeia is the Ph. Eur.

此次小修订对应于药典协调过程中依据药典讨论小组（PDG）工作程序的第4 次修订、第2 次勘误。协调药典为《欧洲药典》。
Compared to the general chapter published in Supplement 11.5 of the Ph. Eur., the following changes are proposed:

与《欧洲药典》增补本11.5 中发布的通用章节相比，建议进行以下更改：
Tapped bulk density section:

振实堆密度部分：
- titles of Method 1 and Method 2 changed by adding 'high drop' and 'low drop' to clearly identify the two methods;

-方法1 和方法2 的标题中添加 “高落差” 和 “低落差”，以明确区分这两种方法；
- Figure 3: inclusion of both drop heights as per Method 1 and Method 2;

-图3：纳入方法1 和方法2 的两种落差高度；
- 'Dimensions in millimetres' deleted from below the caption of Figure 3 as dimensions given in the figure itself;

-从图3 标题下方删除 “以毫米为单位的尺寸”，因为尺寸已在图中给出；
- Method 2: significant figure added for the drop (from '3' to '3.0') to indicate the necessary precision.

-方法2：为落差添加有效数字（从 “3” 改为 “3.0”），以表明必要的精度。
5.1.9. Guidelines for using the test for sterility

5.1.9. 无菌检查使用指南
The revised general chapter allows the use of alternative methods according to general chapter 5.1.6. Alternative methods for control of microbiological quality.

修订后的通用章节允许根据通用章节5.1.6 “微生物质量控制的替代方法” 使用替代方法。
In the Precautions against microbial contamination section, the classification for a laminar - air flow cabinet and its location have been removed because this type of information is usually not defined in the Ph. Eur. and is described in other relevant documents (e.g. Annex 1 of the EudraLex - Volume 4: Good manufacturing practice).

在防止微生物污染的预防措施部分，已删除超净工作台的分类及其位置，因为此类信息通常不在《欧洲药典》中定义，而是在其他相关文件（如《欧盟药品法规汇编》第4 卷附录1：良好生产规范）中描述。
The line stating that the sterility test is the only analytical method available to the authorities has been removed.

声明无菌检查是当局可用的唯一分析方法的内容已被删除。
Sampling plan considerations have been completed in order to also provide recommendations for terminally sterilised products and lyophilised products.

取样计划的考虑因素已完善，以便也为最终灭菌产品和冻干产品提供建议。
Recommendations for sterility test invalidation are no longer limited to condition (d) of general chapter 5.6.1. Sterility.

无菌检查失效的建议不再局限于通用章节5.6.1 “无菌” 中的条件(d)。
Editorial changes have been made throughout the text for greater clarity.

为使内容更清晰，全文进行了编辑性修改。
Editorial modification of the French title from "Indications sur l'application de l'essai de stérilité" to "Recommendations pour la réalisation de l'essai de stérilité".

将法语标题从 “Indications sur l'application de l'essai de stérilité” 编辑修改为 “Recommendations pour la réalisation de l'essai de stérilité”。
5.22. Names of herbal drugs used in traditional Chinese medicine

5.22. 中药中使用的草药名称
Table updated to include 2 new monographs.

表格已更新，纳入2 个新专论。
VACCINES FOR VETERINARY USE

兽用疫苗
Foot - and - mouth disease (ruminants) vaccine (inactivated) (0063)

口蹄疫（反刍动物）疫苗（灭活）(0063)
Immunogenicity.

免疫原性。
- the validity criterion and animal welfare statement for the PD50 and PPG tests have been separated for greater clarity;

- 为更清晰起见，PD50 和PPG 试验的有效性标准和动物福利声明已分开。
the wording of the validity criterion for the above - mentioned tests has been clarified (lesions at sites other than the tongue replaced by a reference to lesions on the feet). This is to reflect the current practice of the EU FMD Reference Laboratories and FMD vaccine manufacturers, in that foot lesions, which do not score the same as lesions on the head. Indeed, mouth lesions may be caused by local spread of the virus from the inoculation site and are not necessarily reflective of generalised infection; they should not therefore be recorded.

上述测试的有效性标准措辞已得到澄清（将 “舌部以外部位的病变” 替换为对足部病变的提及）。这是为了反映欧盟口蹄疫（FMD）参考实验室和口蹄疫疫苗制造商的当前做法，即足部病变的评分与头部病变不同。实际上，口腔病变可能是由病毒从接种部位局部传播引起的，不一定反映全身性感染；因此，不应记录这些病变。
HERBAL DRUGS AND HERBAL DRUG PREPARATIONS

草药及草药制剂
Adhatoda vasica leaf (2738)

鸭嘴花（2738）
Assay: methanol content in the test and reference solutions reduced to avoid artefacts and improve shape of peak due to vasicine.

含量测定：降低测试溶液和对照溶液中的甲醇含量，以避免伪影，并改善鸭嘴花碱峰的形状。
Fleeceflower root (2433)

何首乌（2433）
Definition: botanical name updated.

定义：植物学名已更新。
Identification B: illustration of powdered herbal drug introduced and its legend integrated into text of Identification B.

鉴别B：引入了草药粉末的插图，其图例已整合到鉴别B 的文本中。
Identification C: analytical procedure improved, harmonised with that of Polygonum multiflorum stem (2725) and aligned with general chapter 2.8.25.

鉴别C：分析程序得到改进，与何首乌藤（2725）的程序协调一致，并与通论2.8.25 保持一致。
Assay: grade of solvents used in the mobile phase amended in accordance with the Technical Guide (2022).

含量测定：流动相中使用的溶剂等级已根据《技术指南》（2022 年）进行了修订。
Fourstamen stephania root (2478)

千金藤（2478）
Identification B: illustration of powdered herbal drug introduced and its legend integrated into text of Identification B.

鉴别B：引入了草药粉末的插图，其图例已整合到鉴别B 的文本中。
Identification C: analytical procedure improved and aligned with general chapter 2.8.25.

鉴别C：分析程序得到改进，并与通论2.8.25 保持一致。
Assay: grades of solvents used in the mobile phase amended in accordance with the Technical Guide (2022).

含量测定：流动相中使用的溶剂等级已根据《技术指南》（2022 年）进行了修订。
Wild pansy (flowering aerial parts) (1855)

三色堇（开花地上部分）（1855）
Identification: macroscopic description updated; illustration of powdered herbal drug introduced and its legend integrated into text; TLC replaced by high - performance thin - layer chromatography (HPTLC) in accordance with general chapter 2.8.25.

鉴别：宏观描述已更新；引入了草药粉末的插图，其图例已整合到文本中；按照通论2.8.25，薄层色谱法（TLC）已被高效薄层色谱法（HPTLC）取代。
Loss on drying: limit tightened based on batch data.

干燥失重：根据批次数据收紧限度。
Cadmium: maximum limit increased based on batch data.

镉：根据批次数据提高最大限量。
Assay: unspecific absorbance assay replaced by more specific HPLC.

含量测定：非特异性吸光度测定已被更具特异性的高效液相色谱法（HPLC）取代。
HOMOEOPATHIC PREPARATIONS

顺势疗法制剂
Homoeopathic preparations: introduction (90006)

顺势疗法制剂：简介（90006）
Homoeopathic preparations: introduction has been corrected to remove the reference to "general monographs", as from 12.1 the homoeopathic general monographs are no longer located in section 13 Homoeopathic preparations but instead in section 06 General monographs (Homoeopathic preparations (1038), Herbal drugs for homoeopathic preparations (2045), Mother tinctures for homoeopathic preparations (2029), Methods of preparation of homoeopathic stocks and potentisation (2371)) and section 07 Dosage forms (Pillules for homoeopathic preparations (2153), Homoeopathic pillules, impregnated (2079) and Homoeopathic pillules, coated (2786)).

顺势疗法制剂：简介已修正，删除了对 “通论” 的引用，因为从12.1 起，顺势疗法通论不再位于第13 部分顺势疗法制剂中，而是位于第06 部分通论（顺势疗法制剂（1038）、顺势疗法用草药（2045）、顺势疗法母酊剂（2029）、顺势疗法储备液和稀释制备方法（2371））以及第07 部分剂型（顺势疗法小丸（2153）、浸渍顺势疗法小丸（2079）和包衣顺势疗法小丸（2786））中。
MONOGRAPHS

各论
Aluminium hydroxide, hydrated, for adsorption (1664)

用于吸附的水合氢氧化铝（1664）
Sedimentation: the wording has been modified to clarify the requirements.

沉降：措辞已修改，以明确要求。
Nitrates: in terms of the colour produced, the analytical procedure is not able to discriminate between amounts greater than 1 μg; the preparation of the solution has been modified to correct this issue.

硝酸盐：就产生的颜色而言，分析程序无法区分大于1 微克的量；溶液的制备已修改以纠正此问题。
Arsenic: in line with Ph. Eur. implementation strategy for the ICH Q3D guideline on elemental impurities (please see Press release), it is proposed to delete the test.

砷：根据欧洲药典（Ph. Eur.）对人用药品技术要求国际协调理事会（ICH）Q3D 元素杂质指南的实施策略（请参阅新闻稿），建议删除该测试。
Amitriptyline hydrochloride (0464)

盐酸阿米替林（0464）
First identification: tests relabelled due to addition of the second identification sub - section.

首次鉴别：由于添加了第二次鉴别子部分，测试重新命名。
Second identification: sub - section added since the substance is used in pharmacies.

第二次鉴别：由于该物质在药房中使用，添加了子部分。
Related substances: grades of solvents amended in accordance with the Technical Guide (2022).

相关物质：溶剂等级已根据《技术指南》（2022 年）进行修订。
Amlodipine besilate (1491)

苯磺酸氨氯地平（1491）
Impurity I: new LC procedure to control this additional impurity.

杂质I：用于控制这种额外杂质的新液相色谱（LC）程序。
Related substances: in the preparation of reference solution (b), volumes expressed using fewer significant figures due to the qualitative use of this solution; grade of methanol amended in accordance with the Technical Guide.

相关物质：在制备对照溶液（b）时，由于该溶液用于定性，表达的体积使用较少的有效数字；甲醇等级已根据《技术指南》进行修订。
Aprotinin (0580)

抑肽酶（0580）
Molecular weight: corrected to align with Aprotinin concentrated solution (0579).

分子量：已更正，以与抑肽酶浓缩溶液（0579）一致。
Production: a part of the section has been deleted in accordance with the strategy to remove animal tests for histamine and depressor substances and the remainders of these tests from the European Pharmacopoeia (see Bratos M, Kolaj - Robin O, Antoni M, Charton E. Ph. Eur. testing for histamine and depressor substances using guinea - pigs and cats: the end of anera. Strategy for removal of animal tests for histamine aand depressor substances and their vestiges from the Ph. Eur. Pharmeur Bio Sci Notes. 2024:12-206).

生产：根据从《欧洲药典》中去除组胺和降压物质的动物试验及其剩余部分的策略，该部分的一部分已被删除（见布拉托斯（Bratos M）、科拉伊- 罗宾（Kolaj - Robin O）、安东尼（Antoni M）、沙尔通（Charton E）所著《欧洲药典：使用豚鼠和猫进行组胺和降压物质测试：一个时代的终结。从〈欧洲药典〉中去除组胺和降压物质动物试验及其痕迹的策略》，《欧洲药典生物科学札记》，2024 年：12 - 206）。
Aprotinin concentrated solution (0579)

抑肽酶浓缩液（0579）
Production: a part of the section has been deleted in accordance with the strategy to remove animal tests for histamine and depressor substances and the remainders of these tests from the European Pharmacopoeia (see Bratos M, Kolaj - Robin O, Antoni M, Charton E. Ph. Eur. testing for histamine and depressor substances using guinea - pigs and cats: the end of an era. Strategy for removal of animal tests for histamine and depressor substances and their vestiges from the Ph. Eur. Pharmaceut Bio Sci Notes. 2024 - 12 - 26).

生产：根据从《欧洲药典》中去除组胺和降压物质的动物试验及其残余的策略，本部分的一部分已被删除（见Bratos M、Kolaj - Robin O、Antoni M、Charton E.《欧洲药典》用豚鼠和猫进行组胺和降压物质检测：一个时代的结束。从《欧洲药典》中去除组胺和降压物质的动物试验及其痕迹的策略。药物生物科学注释，2024 - 12 - 26）。
Bromperidol decanoate (1397)

癸酸溴哌利多（1397）
Related substances: additional experimental verification revealed that the elution order of the late eluting impurities D, K and E was incorrect (impurity D eluting before impurities K and E); impurities specified updated to reflect the quality of substances in approved medicinal products on the European market; system suitability criterion amended to take into account the most critical pairs and the correct elution order of the impurities.

有关物质：额外的实验验证表明，后期洗脱杂质D、K 和E 的洗脱顺序不正确（杂质D 在杂质K 和E 之前洗脱）；更新了规定的杂质，以反映欧洲市场上已批准药品中物质的质量；修改了系统适用性标准，以考虑最关键的杂质对和杂质的正确洗脱顺序。
Assay: colour indicator replaced by potentiometric end - point determination.

含量测定：用电位终点测定法取代颜色指示剂。
Butylhydroxytoluene (0581)

丁基羟基甲苯（0581）
Definition: content limits added.

定义：增加了含量限度。
Characters: solubility in heptane added.

性状：增加了在庚烷中的溶解性。
Identification: former first identification tests replaced by state - of - the - art analytical procedures (IR and a test cross - referencing the assay); in second identification, the three tests have been replaced by a TLC procedure based on the TLC method originally described for related substances, that can discriminate between butylhydroxytoluene and butylhydroxyanisole.

鉴别：以前的首次鉴别试验被先进的分析程序（红外光谱和与含量测定相关的一项试验）所取代；在第二次鉴别中，三项试验已被一种基于最初为有关物质所述的薄层色谱法的薄层色谱程序所取代，该程序可以区分丁基羟基甲苯和丁基羟基茴香醚。
Freezing point: test deleted as it has become obsolete with the introduction of a test for purity based on LC instead of TLC.

冰点：该试验已删除，因为随着采用基于液相色谱（LC）而非薄层色谱（TLC）的纯度试验，该试验已过时。
Related substances: former TLC method replaced by new UHPLC - UV method covering 11 new impurities.

有关物质：以前的薄层色谱法被新的超高效液相色谱- 紫外检测法（UHPLC - UV）取代，该方法涵盖11 种新杂质。
Water: test introduced.

水分：引入了检测项目。
Assay: added.

含量测定：增加。
Impurities: section introduced in accordance with the new test for related substances.

杂质：根据有关物质的新检测方法引入了该部分。
Charcoal, activated (0313)

活性炭（0313）
Solution S: following deletion of the analytical procedures used for copper, lead and zinc, this solution is no longer needed and has been deleted.

溶液S：在删除了用于铜、铅和锌的分析程序后，该溶液不再需要，已被删除。
Copper, Lead: in line with the Ph. Eur. implementation strategy for the ICH Q3D guideline on elemental impurities (please see Press release), these tests will be kept with the current limits. In addition, the following impurities will be added: cobalt (5 ppm), nickel (20 ppm) and vanadium (10 ppm); a certain degree of flexibility in the choice of method to be used has been introduced.

铜、铅：根据《欧洲药典》对国际人用药品注册技术协调会（ICH）Q3D 元素杂质指南的实施策略（请见新闻稿），这些检测将保留现行限度。此外，将添加以下杂质：钴（5 ppm）、镍（20 ppm）和钒（10 ppm）；在方法选择上引入了一定程度的灵活性。
Zinc: the test will be kept with the current limit and a certain degree of flexibility in the choice of method to be used has been introduced.

锌：该测试将维持现行限度，并在所用方法的选择上引入了一定程度的灵活性。
Chymotrypsin (0476)

胰凝乳蛋白酶（0476）
Production: a part of the section has been deleted in accordance with the strategy to remove animal tests for histamine and depressor substances and the remainders of these tests from the European Pharmacopoeia (see Stratos M. Kolaj - Robin, Antoni M. Chatton E. Ph. Eur. testing for histamine and depressor substances using guinea - pigs and cats: the end of an era. Strategy for removal of animal tests for histamine and depressor substances and their vestiges from the Ph. Eur. Pharmaceut Bio Sci Notes. 2024:12 - 26).

生产：根据从《欧洲药典》中去除组胺和降压物质的动物试验以及这些试验剩余部分的策略，该部分内容已被删除（见Stratos M. Kolaj - Robin，Antoni M. Chatton，《欧洲药典》使用豚鼠和猫进行组胺和降压物质测试：一个时代的结束。从《欧洲药典》中去除组胺和降压物质动物试验及其痕迹的策略。药物生物科学注释，2024：12 - 26）。
Editorial changes have also been made throughout the monograph. Notably, the description of the colour was updated from purple to reddish - violet as per Style Guide.

在整个专论中也进行了编辑方面的修改。值得注意的是，根据风格指南，颜色描述从紫色更新为红紫色。
Clomipramine hydrochloride (0889)

盐酸氯米帕明（0889）
First identification: tests relabelled due to addition of the second identification sub - section.

首次鉴别：由于增加了第二个鉴别子部分，对测试进行了重新标记。
Second identification: sub - section added since the substance is used in pharmacies.

二次鉴别：由于该物质在药房中使用，增加了子部分。
Related substances: reagent used to describe the stationary phase modified; grade of water in the mobile phase amended in accordance with the Technical Guide (2022); in the preparation of reference solution (c), volume and mass expressed using fewer significant figures due to the qualitative use of this solution.

有关物质：用于描述固定相的试剂已修改；流动相中的水的级别已根据《技术指南》（2022 年）进行修订；在制备对照溶液（c）时，由于该溶液为定性使用，体积和质量用较少的有效数字表示。
Clonazepam (0890)

氯硝西泮（0890）

Identification by IR: use of a reference standard as an alternative to reference spectrum.

红外鉴别：使用参比标准品作为参比光谱的替代方法。
Related substances: impurities specifications updated to reflect the quality of substances in approved medicinal products on the European market; only impurity B is now specified at 0.10%; the system suitability criterion has been modified to avoid the use of an external compound.

有关物质：杂质规范已更新，以反映欧洲市场上已批准药品中物质的质量；现在仅规定杂质B 为0.10%；系统适用性标准已修改，以避免使用外部化合物。
Clopidogrel besilate (2790)

硫酸氢氯吡格雷（2790）
Identification: the ratio between the peaks due to besilate and clopidogrel in test D has been deleted, as the main peak has been found to be outside the linear range of the UV - detector. The requirement for similar retention time of the peaks due to besilate in test and reference solutions has been sufficient to properly identify the besilate ions.

鉴别：测试D 中硫酸根和氯吡格雷峰之间的比率已被删除，因为发现主峰超出了紫外检测器的线性范围。测试溶液和对照溶液中硫酸根峰的保留时间相似这一要求已足以正确鉴别硫酸根离子。
Enantiomeric purity: in the preparation of reference solution (a), volume expressed using fewer significant figures due to the qualitative use of this solution.

对映体纯度：在制备对照溶液（a）时，由于该溶液为定性使用，体积用较少的有效数字表示。
Related substances: in the preparation of reference solutions (b) and (d), volume expressed using fewer significant figures due to the qualitative use of this solution.

有关物质：在制备对照溶液（b）和（d）时，由于该溶液为定性使用，体积用较少的有效数字表示。
Clopidogrel hydrogen sulfate (2531)

硫酸氢氯吡格雷（2531）
Enantiomeric purity: in the preparation of test solution, mass expressed using more significant figures for better accuracy; calculation method updated to reflect the manufacturer's approach; system suitability test updated for the signal - to - noise ratio to verify the sensitivity of the procedure.

对映体纯度：在制备供试溶液时，为了更高的准确性，质量用更多的有效数字表示；计算方法已更新以反映制造商的方法；系统适用性测试已针对信噪比进行更新，以验证该程序的灵敏度。
Related substances: in the preparation of test solution, mass expressed using more significant figures for better accuracy.

有关物质：在制备供试溶液时，为了更高的准确性，质量用更多的有效数字表示。

Codergocrine mesilate (2060)
甲磺酸双氢麦角毒碱（2060）

Assay: for the calculation of codergocrine mesilate content, correction factors updated to better reflect the difference in absorption coefficient between dihydroergocristine mesilate and the 3 other components.
含量测定：为计算甲磺酸双氢麦角毒碱的含量，更新了校正因子，以更好地反映甲磺酸双氢麦角汀与其他3 种成分在吸收系数上的差异。

Danaparoid sodium (2090)
达那肝素钠（2090）

Structural formula: modified to simplify labelling of substituents (from R1 - 6 to R and R').
结构式：进行了修改，以简化取代基的标记（从R1 - 6 改为R 和R'）。

Production: a part of the section has been deleted in accordance with the strategy to remove animal tests for histamine and depressor substances and the remainders of these tests from the European Pharmacopoeia (see Bratos M, Kolaj - Robin O, Antoni M, Charton E. Ph. Eur. testing for histamine and depressor substances using guinea - pigs and cats: the end of an era. Strategy for removal of animal tests for histamine and depressor substances and their vestiges from the Ph. Eur. Pharmeur Bio Sci Notes. 2024:12 - 26).
生产：根据从《欧洲药典》中去除组胺和降压物质的动物试验及这些试验剩余部分的策略，该部分内容已被删除（见Bratos M, Kolaj - Robin O, Antoni M, Charton E.《欧洲药典》用豚鼠和猫进行组胺和降压物质检测：一个时代的终结。从《欧洲药典》中去除组胺和降压物质动物试验及其痕迹的策略。Pharmeur 生物科学笔记。2024:12 - 26）。

The sentence referring to minimising or eliminating endotoxins has also been deleted. This aspect is addressed in the Tests section.
提及尽量减少或消除内毒素的句子也已被删除。这方面内容在 “检测” 部分阐述。

Daunorubicin hydrochloride (0662)
盐酸柔红霉素（0662）

Production: the section has been deleted in accordance with the strategy to remove animal tests for histamine and depressor substances and the remainders of these tests from the European Pharmacopoeia (see Bratos M, Kolaj - Robin O, Antoni M, Charton E. Ph. Eur. testing for histamine and depressor substances using guinea - pigs and cats: the end of an era. Strategy for removal of animal tests for histamine and depressor substances and their vestiges from the Ph. Eur. Pharmeur Bio Sci Notes. 2024:12 - 26).
生产：根据从《欧洲药典》中去除组胺和降压物质的动物试验及这些试验剩余部分的策略，该部分内容已被删除（见Bratos M, Kolaj - Robin O, Antoni M, Charton E.《欧洲药典》用豚鼠和猫进行组胺和降压物质检测：一个时代的终结。从《欧洲药典》中去除组胺和降压物质动物试验及其痕迹的策略。Pharmeur 生物科学笔记。2024:12 - 26）。

Dicloxacillin sodium (0663)
双氯西林钠（0663）

Production: as some manufacturers may choose not to use N,N - dimethylaniline in their production process anymore, the presence of this impurity is now controlled using a risk - based approach. As this aspect cannot always be verified by an independent analyst, the requirement for testing N,N - dimethylaniline has been removed from the Tests section and a Production option has been introduced.
生产：由于一些制造商可能不再选择在生产过程中使用N,N - 二甲基苯胺，现在使用基于风险的方法控制这种杂质的存在。由于这方面内容不能总是由独立分析师验证，检测N,N - 二甲基苯胺的要求已从 “检测” 部分删除，并引入了一个生产选项。

Specific optical rotation: the test has been removed as the quality is adequately controlled with the improved method for related substances.
比旋度：该检测已被删除，因为相关物质的改进方法已能充分控制质量。

Related substances: an improved LC method is proposed with limits based on the quality of the substance used in the manufacture of currently approved products.
有关物质：提出了一种改进的液相色谱（LC）方法，其限度基于目前已批准产品生产中所用物质的质量。

N,N - dimethylaniline: see Production section above.
N,N - 二甲基苯胺：见上文 “生产” 部分。

Assay: a revised method has been introduced based on the improved LC method used for related substances.
含量测定：基于用于有关物质的改进液相色谱方法，引入了一种修订的方法。

Impurities: additional impurities have been included and structures modified based on currently available data.
杂质：根据目前可用的数据，纳入了额外的杂质并修改了结构。

Dosulepin hydrochloride (1314)
盐酸多塞平（1314）

First identification: tests relabelled due to changes in the second identification.
首次鉴别：由于第二次鉴别的变化，对检测进行了重新标记。

Second identification: former test A (by UV) deleted since not feasible in pharmacies; former test C (colour reaction) deleted as considered superfluous; new double detection introduced.
二次鉴别：先前的测试A（通过紫外线）因在药房不可行而删除；先前的测试C（颜色反应）因被认为多余而删除；引入了新的双重检测。

Escitalopram (2758)
艾司西酞普兰（2758）

Related substances: grades of solvents amended in accordance with the Technical Guide; in the preparation of the test solution, mass expressed using more significant figures for better accuracy; in the preparation of reference solution (a), volume expressed using fewer significant figures due to the qualitative use of this solution.
有关物质：溶剂等级根据技术指南进行了修订；在制备测试溶液时，为了更高的准确性，质量用更多有效数字表示；在制备对照溶液（a）时，由于该溶液的定性用途，体积用较少的有效数字表示。

Enantiomeric purity: grades of solvents amended in accordance with the Technical Guide; in the preparation of reference solution (a), mass and volumes expressed using fewer significant figures due to the qualitative use of this solution; calculation method updated to reflect the manufacturer’s approach; reporting threshold replaced by an additional system suitability test (minimum signal - to - noise ratio) to verify the sensitivity of the procedure.
对映体纯度：溶剂等级根据技术指南进行了修订；在制备对照溶液（a）时，由于该溶液的定性用途，质量和体积用较少的有效数字表示；计算方法更新以反映制造商的方法；报告阈值被额外的系统适用性测试（最小信噪比）取代，以验证该程序的灵敏度。

Escitalopram oxalate (2733)
草酸艾司西酞普兰（2733）

Related substances: grades of solvents amended in accordance with the Technical Guide; in the preparation of the test solution, mass expressed using more significant figures for better accuracy; in the preparation of reference solution (a), volume expressed using fewer significant figures due to the qualitative use of this solution.
有关物质：溶剂等级根据技术指南进行了修订；在制备测试溶液时，为了更高的准确性，质量用更多有效数字表示；在制备对照溶液（a）时，由于该溶液的定性用途，体积用较少的有效数字表示。

Enantiomeric purity: grades of solvents amended in accordance with the Technical Guide; in the preparation of reference solution (a), mass and volumes expressed using fewer significant figures due to the qualitative use of this solution; calculation method updated to reflect the manufacturer’s approach; reporting threshold replaced by an additional system suitability test (minimum signal - to - noise ratio) to verify the sensitivity of the procedure.
对映体纯度：溶剂等级根据技术指南进行了修订；在制备对照溶液（a）时，由于该溶液的定性用途，质量和体积用较少的有效数字表示；计算方法更新以反映制造商的方法；报告阈值被额外的系统适用性测试（最小信噪比）取代，以验证该程序的灵敏度。

Esomeprazole magnesium dihydrate (2787)
埃索美拉唑镁二水合物（2787）

Enantiomeric purity: grades of solvents amended in accordance with the Technical Guide; in the preparation of the test solution, mass expressed using more significant figures for better accuracy; in the preparation of reference solution (a), volumes expressed using fewer significant figures due to the qualitative use of this solution; calculation method updated to reflect the manufacturer’s approach; system suitability test introduced for the signal - to - noise ratio to verify the sensitivity of the procedure.
对映体纯度：溶剂等级根据技术指南进行了修订；在制备测试溶液时，为了更高的准确性，质量用更多有效数字表示；在制备对照溶液（a）时，由于该溶液的定性用途，体积用较少的有效数字表示；计算方法更新以反映制造商的方法；引入了针对信噪比的系统适用性测试，以验证该程序的灵敏度。

Related substances: in the preparation of the test solution, mass expressed using more significant figures for better accuracy; in the preparation of reference solutions (a) and (b), volumes expressed using fewer significant figures due to the qualitative use of these solutions.
有关物质：在制备测试溶液时，为了更高的准确性，质量用更多有效数字表示；在制备对照溶液（a）和（b）时，由于这些溶液的定性用途，体积用较少的有效数字表示。

Esomeprazole magnesium trihydrate (2372)
埃索美拉唑镁三水合物（2372）

Enantiomeric purity: grades of solvents amended in accordance with the Technical Guide; in the preparation of the test solution, mass expressed using more significant figures for better accuracy; in the preparation of reference solution (a), volumes expressed using fewer significant figures due to the qualitative use of this solution; calculation method updated to reflect the manufacturer’s approach; system suitability test introduced for the signal - to - noise ratio to verify the sensitivity of the procedure.
对映体纯度：溶剂等级根据技术指南进行了修订；在制备测试溶液时，为了更高的准确性，质量用更多有效数字表示；在制备对照溶液（a）时，由于该溶液的定性用途，体积用较少的有效数字表示；计算方法更新以反映制造商的方法；引入了针对信噪比的系统适用性测试，以验证该程序的灵敏度。

Related substances: in the preparation of the test solution, mass expressed using more significant figures for better accuracy; in the preparation of reference solutions (a) and (b), volumes expressed using fewer significant figures due to the qualitative use of these solutions.

相关物质：在制备供试溶液时，为提高准确度，质量的表示使用更多有效数字；在制备对照溶液(a) 和(b) 时，由于这些溶液用于定性，体积的表示使用较少的有效数字。
Esomeprazole sodium (2923)

埃索美拉唑钠（2923）
Enantiomeric purity: in the preparation of the test solution, mass expressed using more significant figures for better accuracy; calculation method updated to reflect the manufacturer's approach; reporting threshold replaced by an additional system suitability test (minimum signal - to - noise ratio) to verify the sensitivity of the procedure.

对映体纯度：在制备供试液时，为提高准确性，使用更多有效数字表示质量；更新计算方法以反映制造商的方法；用额外的系统适用性试验（最低信噪比）取代报告阈值，以验证该程序的灵敏度。
Related substances: in the preparation of the test solution, mass expressed using more significant figures for better accuracy.

有关物质：在制备供试液时，为提高准确性，使用更多有效数字表示质量。
Fluconazole (2287)

氟康唑（2287）
Related substances: the quantitative style has been introduced; limits for impurities B and C were updated to reflect the quality of the substances in approved medicinal products on the European market; the description of the stationary phase has been amended.

有关物质：引入了定量方式；更新了杂质B 和C 的限度，以反映欧洲市场上已批准药品中物质的质量；修改了固定相的描述。
Fluticasone propionate (1750)

丙酸氟替卡松（1750）
Related substances: the description of reference solution (c) has been changed due to a change in the preparation of the CRS for system suitability.

有关物质：由于系统适用性用对照品溶液（CRS）制备方法的改变，对照溶液（c）的描述已更改。
Follitropin (2285)

促卵泡生成素（2285）
Assay: the procedure has been modified to remove the mercury - containing compound thiomersal (REACH) as an example of a suitable antimicrobial preservative.

含量测定：已修改程序，以去除含汞化合物硫柳汞（REACH 法规相关）作为合适的抗菌防腐剂示例。
Follitropin concentrated solution (2286)

促卵泡生成素浓缩溶液（2286）
Assay: the procedure has been modified to remove the mercury - containing compound thiomersal (REACH) as an example of a suitable antimicrobial preservative.

含量测定：已修改程序，以去除含汞化合物硫柳汞（REACH 法规相关）作为合适的抗菌防腐剂示例。
Glycerol dibehenate (1427)

二山嵛酸甘油酯（1427）
Assay: column diameter changed from 7 mm to 7.5 mm. Columns with a diameter of 7 mm are no longer manufactured.

含量测定：柱直径从7 毫米改为7.5 毫米。直径为7 毫米的色谱柱不再生产。
Glycerol distearate (1428)

二硬脂酸甘油酯（1428）
Assay: column diameter changed from 7 mm to 7.5 mm. Columns with a diameter of 7 mm are no longer manufactured.

含量测定：柱直径从7 毫米改为7.5 毫米。直径为7 毫米的色谱柱不再生产。
Glycerol monolaurate (1429)

单月桂酸甘油酯（1429）
Assay: column diameter changed from 7 mm to 7.5 mm. Columns with a diameter of 7 mm are no longer manufactured.

含量测定：柱直径从7 毫米改为7.5 毫米。直径为7 毫米的色谱柱不再生产。
Glycerol mono - oleate (1430)

单油酸甘油酯（1430）
Assay: column diameter changed from 7 mm to 7.5 mm. Columns with a diameter of 7 mm are no longer manufactured.

含量测定：柱直径从7 毫米改为7.5 毫米。直径为7 毫米的色谱柱不再生产。
Glycerol monostearate 40 - 55 (0495)

单硬脂酸甘油酯40 - 55（0495）
Assay: column diameter changed from 7 mm to 7.5 mm. Columns with a diameter of 7 mm are no longer manufactured.

测定：柱直径从7 毫米变为7.5 毫米。直径为7 毫米的柱子不再生产。
Gonadotrophin, chorionic (0498)

绒毛膜促性腺激素（0498）
Assay: the procedure has been modified to remove the mercury - containing compound thiomersal (REACH) as an example of a suitable antimicrobial preservative.

测定：该程序已被修改，以去除含汞化合物硫柳汞（REACH），作为合适的抗菌防腐剂的一个例子。
Haemodialysis, concentrated solutions for (3206)

血液透析浓缩液（3206）
This monograph has been elaborated specifically for concentrated solutions for haemodialysis because they are no longer covered by monograph 0128 which, subsequent to its proposed revision, now describes requirements for final solutions for haemodialysis only.

本专论专门针对血液透析浓缩液进行了阐述，因为它们不再由0128 专论涵盖，0128 专论在其提议修订后，现在仅描述了血液透析最终溶液的要求。
Haemodialysis, solutions, concentrated, water for diluting (1167)

血液透析浓缩溶液，稀释用水（1167）
The monograph has been revised to reflect current practices and to align with the water monographs (Water, purified (0008) and Water for injections (0169)).

该专论已被修订，以反映当前的实践，并与水专论（纯化水（0008）和注射用水（0169））保持一致。
-Definition section: updated to clearly define how the preparation / solution is prepared.

-定义部分：已更新，以明确界定制剂/ 溶液的制备方法。
-Production section: added:

-生产部分：增加了：
-Use of both potable water and water prepared by ion exchange or distillation no longer described to reflect most common current practices.

-不再描述使用饮用水以及通过离子交换或蒸馏制备的水，以反映当前最常见的做法。
-Paragraph on the “surveillance of the quality of water... and analytical methods”moved to the Tests section.

-关于 “水质量监测…… 和分析方法” 的段落已移至测试部分。
-Microbial contamination test renamed “Microbiological monitoring”and moved from Tests section to Production section. The R2A agar test procedure is described and includes the following parameters: medium, time and temperature, as well as preparation of test strains and growth promotion of R2A agar.

-微生物污染测试更名为 “微生物监测”，并从测试部分移至生产部分。描述了R2A 琼脂测试程序，包括以下参数：培养基、时间和温度，以及测试菌株的制备和R2A 琼脂的促生长。
-Tests section:

-测试部分：
-Aluminium: replaced by a more state - of - the - art method which is already included in the other dialysis monographs.

-铝：被一种更先进的方法所取代，该方法已包含在其他透析专论中。
-Heavy metals: Heavy metals test (2.4.8) removed and replaced by an Other elemental impurities test describing the individual metal tests (copper and lead, with applicable limits, and additional elemental impurities) based on a risk assessment approach.

-重金属：重金属测试（2.4.8）已被移除，取而代之的是其他元素杂质测试，该测试基于风险评估方法描述了单个金属测试（铜和铅，以及适用的限度，和其他元素杂质）。
Bacterial endotoxins: the text now allows the use of the recombinant factor C (rFC) test for the control of bacterial endotoxins.

细菌内毒素：文本现在允许使用重组C 因子（rFC）测试来控制细菌内毒素。
Haemodialysis, solutions for (0128)

血液透析溶液（0128）
The previous version of this monograph described both concentrated and final solutions for haemodialysis. The revised monograph focuses exclusively on final solutions. Consequently, major changes have been made to the Definition, Tests and Labelling sections.

本专论的先前版本描述了血液透析的浓缩溶液和最终溶液。修订后的专论仅关注最终溶液。因此，对定义、测试和标签部分进行了重大修改。
-Definition section:

-定义部分：
-Updated to cover both solutions prepared on - line and provided in containers.

-已更新，以涵盖在线制备和容器中提供的溶液。
-Formulation composition tables: addition of the use of citrate and citric/lactic acids and correction of the concentration range (potassium, acids) to reflect the current products on the market.

-配方组成表：添加柠檬酸盐和柠檬酸/ 乳酸的使用情况，并修正浓度范围（钾、酸）以反映市场上的现有产品。
-Addition of a statement about the use of antioxidants.

-添加关于抗氧化剂使用的说明。
-Identification section: addition of citrates.

-鉴别部分：添加柠檬酸盐。
-Tests section:

-测试部分：
-Inclusion of new tests (pH, Hydroxymethylfurfural, Particulate contamination and Citrate).

-纳入新的测试项目（pH、羟甲基糠醛、颗粒污染和柠檬酸盐）。
-Lactate and hydrogen carbonate assay has been added to offer possibility to perform both tests simultaneously in alignment with monograph 0861.

-已添加乳酸盐和碳酸氢盐测定法，以便能够根据专论0861 同时进行这两项测试。
-Assay section: inclusion of the citrate assay.

-含量测定部分：纳入柠檬酸盐测定法。
Haemofiltration and haemodiafiltration, concentrated solutions for (2770)

血液滤过和血液透析滤过用浓缩液（2770）
The monograph has been revised to reflect current practices and to align it with other dialysis monographs (i.e. 0128, 0861, 0862).

该专论已修订，以反映当前的实践，并使其与其他透析专论（即0128、0861、0862）保持一致。
-Definition section:

-定义部分：
-Addition of a definition of the final and ready - to - use solutions.

-添加最终和即用型溶液的定义。
-Addition of a statement about the three types of concentrated solutions used.

-添加关于所使用的三种浓缩溶液的说明。
-Removal of the table giving the composition of the concentrated formulations and making reference to Haemofiltration and haemodiafiltration, solutions for (0861).

-删除给出浓缩配方组成的表格，并提及血液滤过和血液透析滤过用溶液（0861）。
-Removal of the statement on the use of hydrogen carbonate, which does not apply to haemofiltration and haemodiafiltration.

-删除关于碳酸氢盐使用的说明，该说明不适用于血液滤过和血液透析滤过。
-Clarification for the statement about the use of antioxidants.

-对关于抗氧化剂使用的说明进行澄清。
-Identification section: removal of carbonates and hydrogen carbonates, which is specific to ready - to - use haemofiltration and haemodiafiltration solutions.

-鉴别部分：删除即用型血液滤过和血液透析滤过溶液特有的碳酸盐和碳酸氢盐。
-Tests section:

-测试部分：
-pH: addition of clarification that the limits apply to ready - to - use solutions; adding new limits when the solution contains hydrogen carbonate.-pH：

添加说明，限值适用于即用型溶液；当溶液含有碳酸氢盐时添加新的限值。
-Aluminium: addition of clarification that the limit applies to final solutions.

-铝：添加说明，限值适用于最终溶液。
-Hydroxymethylfurfural: clarification that this test applies when the preparation contains glucose and is heat - sterilised.

-羟甲基糠醛：澄清当制剂含有葡萄糖并经过热灭菌时适用此测试。
-Microbial contamination: inclusion of new test parameter when the preparation is not claimed to be sterile.

-微生物污染：当制剂未声称无菌时，纳入新的测试参数。
-Pyrogenicity: addition of new test in accordance with the new requirement in general chapter 5.1.13.

-热原性：根据通则5.1.13 中的新要求添加新测试。
Haemofiltration and haemodiafiltration, solutions for (0861)血液滤过和血液透析滤过用溶液（0861）
The monograph has been revised to reflect current practices and align with the other dialysis monographs (i.e. 0128, 0862 and 2770).

该专论已修订，以反映当前的实践，并与其他透析专论（即0128、0862 和2770）保持一致。
-Definition section:

-定义部分：
-Addition of a statement on the on - line preparation by diluting concentrated solutions and clarification between the on - line preparations and ready - to - use preparations/solutions.

-添加关于通过稀释浓缩溶液进行在线制备以及在线制剂和即用制剂/ 溶液之间澄清的说明。
-Addition of a statement on the use of antioxidants.

-添加关于抗氧化剂使用的说明。
-Formulation compositions table: addition of the use of citrate/citric acid.

-配方组成表：添加柠檬酸盐/ 柠檬酸的使用说明。
-Identification section: Addition of citrates since citrate has been added as a component of the haemofiltration and haemodiafiltration preparations.

-鉴别部分：添加柠檬酸盐，因为柠檬酸盐已作为血液滤过和血液透析滤过制剂的一种成分添加。
-Tests section:

-测试部分：
-Hydroxymethylfurfural: addition of the clarification that this test applies when (a) the solution is provided in containers, contains glucose and is heat - sterilised, or (b) the solution is prepared on - line and is produced from heat - sterilised concentrates containing glucose.

-羟甲基糠醛：添加说明，当（a）溶液装在容器中，含有葡萄糖并经过热灭菌，或（b）溶液在线制备且由含有葡萄糖的热灭菌浓缩物生产时，适用此测试。
-Extractable volume: addition of clarification that this test applies to solutions packaged in containers.

-可提取体积：添加说明，此测试适用于装在容器中的溶液。
-Assay section: inclusion of the citrate assay since citrate has been added as a component of the haemofiltration and haemodiafiltration preparations.

-含量测定部分：纳入柠檬酸盐含量测定，因为柠檬酸盐已作为血液滤过和血液透析滤过制剂的一种成分添加。
-Labelling section: addition of the requirement that the haemofiltration and haemodiafiltration solution is sterile.

-标签部分：添加血液滤过和血液透析滤过溶液必须无菌的要求。
Hard fat (0462)

硬脂（0462）
Hydroxyl value: possibility of performing the titration on a warmed solution introduced to avoid potential congealing.

羟值：可以对温热的溶液进行滴定，以避免潜在的凝结。
Hard fat with additives (2731)

含添加剂的硬脂（2731）
Hydroxyl value: possibility of performing the titration on a warmed solution introduced to avoid potential congealing.

羟值：可以对温热的溶液进行滴定，以避免潜在的凝结。
Heparin calcium (0332)

肝素钙（0332）
Production: a part of the section has been deleted in accordance with the strategy to remove animal tests for histamine and depressor substances and the remainders of these tests from the European Pharmacopoeia, (see Bratos M, Kolaj - Robin O, Antoni M, Charton E. Ph. Eur. testing for histamine and depressor substances using guinea - pigs and cats: the end of an era. Strategy for removal of animal tests for histamine and depressor substances and their vestiges from the Ph. Eur. Pharmacopoeia Bio Sci Notes. 2024:12 - 26).

生产：根据从《欧洲药典》中去除组胺和降压物质的动物试验以及这些试验剩余部分的策略，该部分的一部分已被删除（见Bratos M、Kolaj - Robin O、Antoni M、Charton E.《欧洲药典》用豚鼠和猫进行组胺和降压物质测试：一个时代的结束。从《欧洲药典》中去除组胺和降压物质动物试验及其痕迹的策略。药典生物科学笔记，2024：12 - 26）。
Heparin sodium (0333)肝素钠（0333）
Production: a part of the section has been deleted in accordance with the strategy to remove animal tests for histamine and depressor substances and the remainders of these tests from the European Pharmacopoeia (see Bratos M, Kolaj - Robin O, Antoni M, Charton E. Ph. Eur. testing for histamine and depressor substances using guinea - pigs and cats: the end of an era. Strategy for removal of animal tests for histamine and depressor substances and their vestiges from the Ph. Eur. Pharmacopoeia Bio Sci Notes. 2024:12 - 26).

生产：根据从《欧洲药典》中去除组胺和降压物质的动物试验以及这些试验剩余部分的策略，该部分的一部分已被删除（见Bratos M、Kolaj - Robin O、Antoni M、Charton E.《欧洲药典》用豚鼠和猫进行组胺和降压物质测试：一个时代的结束。从《欧洲药典》中去除组胺和降压物质动物试验及其痕迹的策略。药典生物科学笔记，2024：12 - 26）。
Heparins, low - molecular - mass (0828)

低分子量肝素（0828）
Identification C: the preparation of the reference solution was adapted taking into account the amount of heparin low - molecular - mass for calibration CRS 6 per vial.

鉴别C：参考溶液的制备考虑了每瓶用于校准的低分子量肝素对照品6 的量进行了调整。
Homatropine hydrobromide (0500)

氢溴酸后马托品（0500）
Characters: melting point deleted.

性状：熔点删除。
Related substances: grades of solvents amended in accordance with the Technical Guide;

有关物质：溶剂等级根据技术指南进行了修订；
in the preparation of reference solution (b), volume expressed using fewer significant figures due to qualitative use of this solution; requirement for the symmetry factor deleted;

在制备对照溶液（b）时，由于该溶液为定性使用，体积以较少的有效数字表示；对称因子的要求删除；
quantitative style now prescribed; introduction of a limit at 0.10 per cent for unspecified impurities; impurity limits updated to reflect current quality of the products on the market;

现在规定了定量方式；引入了未指定杂质0.10% 的限度；杂质限度进行了更新以反映市场上产品的当前质量；
impurities A, B, C and D listed as unspecified impurities; limit for total impurities tightened from 1.0 per cent to 0.5 per cent.

杂质A、B、C 和D 列为未指定杂质；总杂质限度从1.0% 收紧至0.5%。
Hydroxyethylcellulose (0336)

羟乙基纤维素（0336）
Functionality - related characteristics: the section has been revised to add, in addition to its use as a viscosity - increasing agent, the following characteristics that may be considered critical and useful material attributes when hydroxyethylcellulose is used as a matrix former for modified - release solid dosage forms: viscosity and molar substitution (cross - references);

功能性相关特性：该部分已修订，除了其作为增粘剂的用途外，当羟乙基纤维素用作缓释固体剂型的基质形成剂时，还添加了以下可被视为关键且有用的材料属性：粘度和摩尔取代度（相互参照）；
molecular - mass distribution, particle - size distribution and powder flow (references to Ph. Eur. general chapters). The term 'degree of substitution' has been replaced by'molar substitution'.

分子量分布、粒度分布和粉末流动性（参考欧洲药典通则）。“取代度” 一词已被 “摩尔取代度” 取代。
The entire non - mandatory Functionality - related characteristics section is marked with white diamonds to indicate its status as a local Ph. Eur. requirement of this PDG harmonised monograph.

整个非强制性的功能性相关特性部分用白色菱形标记，以表明其作为本PDG 协调专论的欧洲药典地方要求的地位。
Hydroxypropyl cellulose, low - substituted (2083)

低取代羟丙基纤维素（2083）
Assay: calculation updated to align with the PDG sign - off text.

含量测定：计算方法更新以与PDG 批准文本一致。
Hypromellose (0348)

羟丙甲纤维素（0348）
Assay: calculation updated to align with the PDG sign - off text.

含量测定：计算方法更新以与 PDG 批准文本一致。
Indometacin (0092)

吲哚美辛（0092）
Characters: solubility in heptane added.

性状：增加了在庚烷中的溶解性。
Related substances: concentration of formic acid in mobile phases A and B corrected in accordance with the procedure as originally validated during elaboration of the monograph.

有关物质：流动相A 和B 中甲酸的浓度根据在制定该专论时最初验证的程序进行了校正。
Assay: concentration of acetic acid in mobile phases A and B corrected by referring to the right reagent, thus in accordance with the procedure as originally validated during elaboration of the monograph.

含量测定：流动相A 和B 中乙酸的浓度通过参考正确的试剂进行了校正，因此符合在制定该专论时最初验证的程序。
Kanamycin sulfate (0033)

硫酸卡那霉素（0033）
Formula: the chemical structure has been introduced.

分子式：引入了化学结构。

Definition: the chemical nomenclature has been introduced. The definition now shows that the substance contains a variable quantity of sulfuric acid and water, and that it is produced from kanamycin monosulfate hydrate.

定义：引入了化学命名法。现在的定义表明该物质含有可变数量的硫酸和水，并且它是由硫酸卡那霉素一水合物生产的。
Production: the section has been deleted in accordance with the strategy to remove animal tests for histamine and depressor substances and the remainders of these tests from the European Pharmacopoeia (see Bratos M., Kolaj - Robin O., Antoni M., Charton E. Ph. Eur. testing for histamine and depressor substances using guinea - pigs and cats: the end of an era. Strategy for removal of animal tests for histamine and depresssor substances and their vestiges from the Ph. Eur. Pharmeur Bio Sci Notes. 2024:12-26).

生产：根据从《欧洲药典》中去除组胺和降压物质的动物试验以及这些试验剩余部分的策略，该部分已被删除（见布拉托斯（Bratos M.）、科拉伊- 罗宾（Kolaj - Robin O.）、安东尼（Antoni M.）、沙尔通（Charton E.）所著《欧洲药典使用豚鼠和猫进行组胺和降压物质测试：一个时代的终结。从〈欧洲药典〉中去除组胺和降压物质的动物试验及其痕迹的策略》，《欧洲药典生物科学通讯》，2024 年：12 - 26 页）。
Kanamycin monosulfate monohydrate (0032)

硫酸卡那霉素单水合物（0032）
Production: the section has been deleted in accordance with the strategy to remove animal tests for histamine and depressor substances and the remainders of these tests from the European Pharmacopoeia (see Bratos M, Kolaj-Robin O, Antoni M, Charton E. Ph. Eur. testing for histamine and depressor substances using guinea - pigs and cats: the end of an era. Strategy for removal of animal tests for histamine and depressor substances and their vestiges from the Ph. Eur. Pharmer Bio Sci Notes. 2024;12 - 26).

生产：根据从《欧洲药典》中去除组胺和降压物质的动物试验及其残余的策略，该部分已被删除（见Bratos M、Kolaj - Robin O、Antoni M、Charton E.《欧洲药典》使用豚鼠和猫进行组胺和降压物质检测：一个时代的结束。从《欧洲药典》中去除组胺和降压物质的动物试验及其痕迹的策略。Pharmer 生物科学笔记，2024 年；12 - 26）。
Lacosamide (292)

拉科酰胺（292）
Enantiomeric purity: in the preparation of reference solutions (a) and (b), volumes expressed using fewer significant figures due to the qualitative use of these solutions; calculation method updated to reflect the manufacturer's approach; reporting threshold replaced by an additional system suitability test (minimum signal - to - noise ratio) to verify the sensitivity of the procedure.

对映体纯度：在制备对照溶液（a）和（b）时，由于这些溶液的定性使用，体积用较少的有效数字表示；计算方法已更新以反映制造商的方法；报告阈值被额外的系统适用性测试（最小信噪比）取代，以验证该程序的灵敏度。
Related substances: in the preparation of reference solutions (c) and (d), volumes expressed using fewer significant figures due to the qualitative use of these solutions.

有关物质：在制备对照溶液（c）和（d）时，由于这些溶液的定性使用，体积用较少的有效数字表示。
Lamivudine (2217)

拉米夫定（2217）
Enantiomeric purity: in the preparation of reference solution (a), volume expressed using fewer significant figures due to the qualitative use of this solution; calculation method updated to reflect the manufacturer's approach; system suitability test introduced for the signal - to - noise ratio to verify the sensitivity of the procedure.

对映体纯度：在制备对照溶液（a）时，由于该溶液的定性使用，体积用较少的有效数字表示；计算方法已更新以反映制造商的方法；引入了信噪比系统适用性测试以验证该程序的灵敏度。
Impurities

杂质
Levetiracetam (2535)

左乙拉西坦（2535）
Enantiomeric purity: in the preparation of reference solution (a), volume expressed using fewer significant figures due to the qualitative use of this solution; calculation method updated to reflect the manufacturer's approach; reporting threshold replaced by an additional system suitability test (minimum signal - to - noise ratio) to verify the sensitivity of the procedure.

对映体纯度：在制备对照溶液（a）时，由于该溶液的定性使用，体积用较少的有效数字表示；计算方法已更新以反映制造商的方法；报告阈值被额外的系统适用性测试（最小信噪比）取代，以验证该程序的灵敏度。
Impurity G: in the preparation of the test solution, mass expressed using more significant figures for better accuracy; in the preparation of the test solution (c), volumes expressed using fewer significant figures due to the qualitative use of this solution.

杂质G：在制备供试溶液时，为了更高的准确性，质量用更多的有效数字表示；在制备供试溶液（c）时，由于该溶液的定性使用，体积用较少的有效数字表示。
Related substances: in the preparation of reference solution (a), volumes expressed using fewer significant figures due to the qualitative use of this solution.

有关物质：在制备对照溶液（a）时，由于该溶液的定性使用，体积用较少的有效数字表示。
Macrogols (1444)

聚乙二醇（1444）
Functionality - related characteristics: the section has been revised to add, in addition to its use as a solvent, stabiliser, lubricant, thickener and base, the following characteristics that may be considered critical and useful material attributes: macrogols are used as a binder and as a matrix former for modified - release solid dosage forms.

功能性相关特性：该部分已修订，除了其作为溶剂、稳定剂、润滑剂、增稠剂和基质的用途外，还添加了以下可能被视为关键且有用的材料属性：聚乙二醇用作粘合剂和用于缓释固体剂型的基质形成剂。
-for macrogols used as binder: viscosity (cross - reference);

-对于用作粘合剂的聚乙二醇：粘度（相互参照）；
-for macrogols used as a matrix former for modified - release solid dosage forms: viscosity (cross - reference); molecular mass distribution, particle - size distribution and powder flow (references to Ph. Eur. general chapters).

-对于用作缓释固体剂型基质形成剂的聚乙二醇：粘度（交叉引用）；分子量分布、粒度分布和粉末流动性（参考欧洲药典通则章节）。
Few editorial changes have also been made throughout the monograph to align with the current style guide.

在整个专论中也进行了一些编辑上的更改，以符合当前的风格指南。
Macrogols, high - molecular - mass (2444)

高分子量聚乙二醇（2444）
Functionality - related characteristics: a section has been added to introduce characteristics that may be considered critical and useful material attributes when high - molecular mass macrogols are used as a binder and as a matrix former for modified - release solid dosage forms:

与功能相关的特性：添加了一个部分，以介绍当高分子量聚乙二醇用作粘合剂和缓释固体剂型的基质形成剂时，可能被视为关键且有用的材料属性：
for high - molecular - mass macrogols used as a binder: viscosity (cross - reference);

对于用作粘合剂的高分子量聚乙二醇：粘度（交叉引用）；
for high - molecular - mass macrogols used as a matrix former for modified - release solid dosage forms: viscosity (cross - reference); molecular mass distribution, particle - size distribution and powder flow (references to Ph. Eur. general chapters).

对于用作缓释固体剂型基质形成剂的高分子量聚乙二醇：粘度（交叉引用）；分子量分布、粒度分布和粉末流动性（参考欧洲药典通则章节）。
Maize starch (0344)玉米淀粉（0344）
This draft corresponds to Revision 4, Stage 2 (based on the Pharmacopoeial Discussion Group (PDG) working procedure) within the Pharmacopoeial harmonisation process. The coordinating pharmacopoeia is the USP. The original text submitted to the PDG is published in the Pharmacopoeial harmonisation section.

本草案对应于药典协调过程中根据药典讨论小组（PDG）工作程序的第4 次修订，第2 阶段。协调药典是美国药典。提交给PDG 的原始文本发表在药典协调部分。
Compared to the monograph published in the 11th Edition of the Ph. Eur., the following changes are proposed:

与欧洲药典第11 版中公布的专论相比，提出以下更改：
Identification: limits for the diameters of both angular polyhedral granules and rounded/spheroidal granules revised to a maximum of about 35 μm based on the distribution of granule diameters and shapes found by testing maize starch from multiple manufacturers.

鉴别：根据对多家制造商的玉米淀粉测试发现的颗粒直径和形状分布，将角形多面体颗粒和圆形/ 球形颗粒的直径限度修订为最大约35μm。
Methylcellulose (0345)

甲基纤维素（0345）
Assay: calculation updated to align with the PDG sign - off text.

含量测定：计算更新以与PDG 批准文本一致。
Nicotine ditartrate dihydrate (2599)

二水合酒石酸烟碱（2599）
Specific optical rotation: concentration of the solution and range updated; value calculated on the anhydrous substance.

比旋度：溶液浓度和范围更新；数值基于无水物质计算。
Related substances: water for chromatography R used for the preparation of the mobile phase; in the preparation of the test solution, mass expressed using more significant figures; in the preparation of reference solution (a), volume expressed using fewer significant figures due to the qualitative use of this solution.

有关物质：用于制备流动相的色谱用水R；在制备供试溶液时，质量用更多有效数字表示；在制备对照溶液（a）时，由于该溶液的定性用途，体积用较少有效数字表示。
Nitrendipine (1246)

尼群地平（1246）
Related substances: the quantitative style has been introduced; the limit of impurity C was updated; impurity A is now specified at 0.10%. These changes reflect the quality of the substances in approved medicinal products on the European market.

有关物质：引入了定量方式；杂质C 的限度更新；杂质A 现在规定为0.10%。这些更改反映了欧洲市场上已批准药品中物质的质量。
Oxy tetracycline hydrochloride (0198)

盐酸土霉素（0198）
Related substances: dilute hydrochloric acid R1 has been replaced by the stronger dilute hydrochloric acid R in order to reduce the volume of reagent required to perform the pH adjustment of the oxalic acid solution used in the solvent mixture.

有关物质：稀盐酸R1 已被更强的稀盐酸R 取代，以减少对溶剂混合物中所用草酸溶液进行pH 调节所需的试剂量。
Pentobarbital sodium (0419)

戊巴比妥钠（0419）
First identification: tests relabelled due to addition of the second identification sub - section.

第一鉴别：由于添加了第二鉴别子部分，对试验重新进行了标记。
Second identification: sub - section added since the substance is used in pharmacies.

第二鉴别：由于该物质在药房使用，添加了子部分。
Peritoneal dialysis, solutions for (0862)

腹膜透析溶液（0862）
The monograph has been revised to reflect current practices and to align with the other dialysis monographs (0128, 0861 and 2770):

该专论已被修订，以反映当前实践并与其他透析专论（0128、0861 和2770）保持一致：
-Tests section: Hydroxymethylfurfural: addition of clarification that the test is carried out only when the glucose - containing solution is heat - sterilised.-试验部分：

羟甲基糠醛：补充说明仅当含葡萄糖溶液进行热灭菌时才进行该试验。
-Labelling section: addition of the requirement that the peritoneal dialysis solution is sterile.

-标签部分：添加了腹膜透析溶液必须无菌的要求。
Pivmecillinam hydrochloride (1359)

盐酸匹美西林（1359）
Related substances: the preparation of reference solution (c) has been amended to take account the new lyophilised form of pivmecillinam impurity C CRS.

有关物质：对照溶液（c）的制备已作修改，以考虑匹美西林杂质C CRS 的新冻干形式。
Propylene glycol dilaurate (2087)

丙二醇二月桂酸酯（2087）
Assay: column diameter changed from 7 mm to 7.5 mm. Columns with a diameter of 7 mm are no longer manufactured.

含量测定：柱直径从7 毫米改为7.5 毫米。直径为7 毫米的柱子不再生产。
Propylene glycol monocaprylate (2799)

丙二醇单辛酸酯（2799）
Assay: column diameter changed from 7.0 mm to 7.5 mm. Columns with a diameter of 7.0 mm are no longer manufactured.

含量测定：柱直径从7.0 毫米改为7.5 毫米。直径为7.0 毫米的柱子不再生产。
Propylene glycol monolaurate (1915)

丙二醇单月桂酸酯（1915）
Assay: column diameter changed from 7 mm to 7.5 mm. Columns with a diameter of 7 mm are no longer manufactured.

含量测定：柱直径从7 毫米改为7.5 毫米。直径为7 毫米的柱子不再生产。
Remifentanil hydrochloride (2644)

盐酸瑞芬太尼（2644）
Characters: in view of feedback from users, the reference to solubility in acetonitrile has been deleted.

性状：鉴于用户反馈，关于在乙腈中溶解度的表述已被删除。
Identification by IR: the use of a reference spectrum has been added as an alternative to the reference standard.

红外鉴别：已添加使用参考光谱作为参考标准的替代方法。
Methyl acrylate: water for chromatography R has been replaced by an apolar solvent for the preparation of the test solution to avoid in - situ formation of methyl acrylate; the method parameters have been adjusted accordingly.

丙烯酸甲酯：在制备测试溶液时，色谱用水R 已被非极性溶剂取代，以避免现场形成丙烯酸甲酯；方法参数已相应调整。
Rifamycin sodium (0432)

利福霉素钠（0432）
Production: the section has been deleted in accordance with the strategy to remove animal tests for histamine and depressor substances and the remainders of these tests from the European Pharmacopoeia (see Bratos M, Kolaj - Robin O, Antoni M, Charton E. Ph. Eur. testing for histamine and depressor substances using guinea - pigs and cats: the end of an era. Strategy for removal of animal tests for histamine and depressor substances and their vestiges from the Ph. Eur. Pharmeur Bio Sci Notes. 2024;12 - 26).

生产：根据从《欧洲药典》中去除组胺和降压物质的动物试验以及这些试验的残留部分的策略，该部分已被删除（见布拉托斯M、科拉伊- 罗宾O、安东尼M、沙顿E。《欧洲药典》用豚鼠和猫进行组胺和降压物质检测：一个时代的终结。从《欧洲药典》中去除组胺和降压物质的动物试验及其残留的策略。欧洲制药生物科学笔记。2024;12 - 26）。
Rivaroxaban (2932)

利伐沙班（2932）
Enantiomeric purity: in the preparation of the test solution, mass and volume expressed using more significant figures for better accuracy; calculation method moved up; system suitability test introduced to the signal - to - noise ratio to verify the sensitivity of the procedure.

对映体纯度：在制备供试液时，为了更高的准确性，使用更多有效数字表示质量和体积；计算方法提前；引入系统适用性试验以信噪比来验证该程序的灵敏度。
Ropivacaine hydrochloride monohydrate (2335)

盐酸罗哌卡因一水合物（2335）
Enantiomeric purity: calculation method updated to reflect the manufacturer's approach; grade of water used amended in accordance with the Technical Guide; in the preparation of the test solution, mass and volume expressed using more significant figures for better accuracy; in the preparation of reference solution (b), masses expressed using fewer significant figures due to qualitative use of this solution; migration time of ropivacaine and relative migration of impurity G included.

对映体纯度：计算方法更新以反映制造商的方法；所用的水的级别根据技术指南进行了修订；在制备供试液时，为了更高的准确性，使用更多有效数字表示质量和体积；在制备对照溶液（b）时，由于该溶液的定性使用，使用较少的有效数字表示质量；包括罗哌卡因的迁移时间和杂质G 的相对迁移。
Related substances: grades of solvents amended in accordance with the Technical Guide; in the preparation of the test solution, mass and volume expressed using more significant figures for better accuracy.

有关物质：溶剂的级别根据技术指南进行了修订；在制备供试液时，为了更高的准确性，使用更多有效数字表示质量和体积。
Rotigotine (3014)

罗替戈汀（3014）
Enantiomeric purity: calculation method moved up; additional system suitability test (signal - to - noise ratio) introduced to verify the sensitivity of the procedure; in the preparation of test solution, mass and volume expressed using more significant figures for better accuracy.

对映体纯度：计算方法提前；引入额外的系统适用性试验（信噪比）以验证该程序的灵敏度；在制备供试液时，为了更高的准确性，使用更多有效数字表示质量和体积。
Related substances: in the preparation of reference solution (b), volumes expressed using fewer significant figures due to the qualitative use of this solution.

有关物质：在制备对照溶液（b）时，由于该溶液的定性使用，使用较少的有效数字表示体积。
Salicylic acid (0366)

水杨酸（0366）
Solution S: preparation transferred in the only test in which it is used, the test for chlorides.

溶液S：制备转移至其唯一使用的试验中，即氯化物试验。
Related substances: column length decreased reflecting the dimensions of the particular column used in the validation of the proposed optimised procedure; grade of water used in the mobile phase amended in accordance with the Technical Guide (2022); quantitation of impurities optimised, carried out versus a 0.05 per cent impurity B solution; injection volume decreased 5 fold and concentration of the test solution increased 10 fold to achieve sufficient sensitivity; first system suitability test acceptance criterion based on a minimum signal - to - noise ratio of a 0.05 - per cent diluted test solution to ensure the detection of unknown impurities structurally close to the API, since the detector response of the API is lower than the detector response for impurity B which was used to quantitate all impurities; second system suitability test acceptance criterion widened based on recent experimental results injecting the proposed corresponding reference solution; limits expressed in the quantitative style.

有关物质：柱长缩短以反映在验证所提议的优化程序中使用的特定色谱柱的尺寸；流动相中使用的水的级别根据技术指南（2022 年）进行了修订；杂质的定量进行了优化，相对于0.05% 的杂质B 溶液进行；进样体积减少5 倍，供试液浓度增加10 倍以达到足够的灵敏度；第一个系统适用性试验的接受标准基于0.05% 稀释供试液的最低信噪比，以确保检测到与原料药结构相近的未知杂质，因为原料药的检测器响应低于用于定量所有杂质的杂质B 的检测器响应；根据最近注射所提议的相应对照溶液的实验结果，第二个系统适用性试验的接受标准放宽；限度以定量方式表示。
Assay: colorimetric end - point detection replaced by more accurate and precise potentiometric end - point detection.

含量测定：比色终点检测被更准确和精确的电位终点检测所取代。
Impurities: section updated in accordance with the limits in the test for related substances.

杂质：该部分已根据有关物质测试中的限度进行了更新。
Sitagliptin phosphate monohydrate (2778)

磷酸西格列汀一水合物（2778）
Identification C: sample size and volume of solvent expressed using fewer significant figures due to qualitative use of this test.

鉴别C：由于该测试为定性用途，样品量和溶剂量使用较少的有效数字表示。
Enantiomeric purity: in the preparation of the test solution, sample size expressed with one more significant figure due to its use in the preparation of reference solution (a), which is used for a quantitative test; signal - to - noise ratio; calculation method updated to reflect the manufacturer's approach (reporting threshold replaced by an additional system suitability test (minimum signal - to - noise ratio) to verify the sensitivity of the procedure.

对映体纯度：在制备供试液时，由于其用于制备用于定量测试的对照溶液（a），样品量以多一位有效数字表示；信噪比；计算方法已更新，以反映制造商的方法（报告阈值由额外的系统适用性测试（最低信噪比）取代，以验证该程序的灵敏度）。
Sodium hydrogen carbonate (0195)

碳酸氢钠（0195）
Ammonium: based on new data, preparation of solutions amended to bring to a strongly alkaline pH.

铵：根据新数据，溶液的制备进行了修订，使其pH 值呈强碱性。
Sodium polystyrene sulfonate (1909)

聚苯乙烯磺酸钠（1909）
Definition: amended to clarify that the monograph covers a sodium sulfonated copolymer of styrene and divinylbenzene, which has very different properties from the sodium sulfonated polystyrene homopolymer; structure added.

定义：进行了修订，以明确该专论涵盖苯乙烯和二乙烯基苯的磺化钠共聚物，其性质与磺化聚苯乙烯均聚物有很大不同；添加了结构。
Styrene: more accurate quantities mentioned; run time, retention time and chromatogram added; grade of solvent for mobile phase and reagent used to describe the stationary phase amended.

苯乙烯：提及了更准确的数量；添加了运行时间、保留时间和色谱图；对流动相溶剂的级别和用于描述固定相的试剂进行了修订。
Starch, hydroxypropyl (2165)

羟丙基淀粉（2165）
Identification A: Maize - based hydroxypropyl starch criteria revised in - line with the revision to the Maize starch (0344) monograph.

鉴别A：基于玉米的羟丙基淀粉标准已根据玉米淀粉（0344）专论的修订进行了修订。
Starches, hydroxyethyl (1785)

羟乙基淀粉（1785）
Molecular weight (Mw) and molecular weight distribution: system suitability criteria widened in order to better reflect the variability in the method reported by several laboratories; unit specified (daltons); test name revised to 'Molecular weight (Mw) and molecular mass distribution' to accurately describe the value measured by the test (English text only).

分子量（Mw）和分子量分布：系统适用性标准扩大，以便更好地反映几个实验室报告的方法中的变异性；指定了单位（道尔顿）；测试名称修订为 “分子量（Mw）和分子质量分布”，以准确描述测试测量的值（仅英文文本）。
Editorial changes have also been made throughout the monograph to align with the current style guide.

整个专论也进行了编辑修改，以符合当前的风格指南。
Streptomycin sulfate (0053)

硫酸链霉素（0053）
Production: the section has been deleted in accordance with the strategy to remove animal tests for histamine and depressor substances and the remainders of these tests from the European Pharmacopoeia (see Bratos S, Kolaj - Robin O, Antoni M, Charton E. Ph. Eur. testing for histamine and depressor substances using guinea - pigs and cats: the end of an era. Strategy for removal of animal tests for histamine and depressor substances and their vestiges from the Ph. Eur. Pharmeu Bio Sci Notes. 2024 - 12 - 26).

生产：根据从《欧洲药典》中删除组胺和降压物质的动物试验以及这些试验残余的策略，该部分已被删除（见Bratos S、Kolaj - Robin O、Antoni M、Charton E.《欧洲药典》使用豚鼠和猫进行组胺和降压物质测试：一个时代的结束。从《欧洲药典》中删除组胺和降压物质的动物试验及其残余的策略。Pharmeu Bio Sci Notes. 2024 - 12 - 26）。
Editorial changes have also been made throughout the monograph.

整个专论也进行了编辑修改。
Sucrose monopalmitate (2319)

单棕榈酸蔗糖酯（2319）
Assay: column diameter changed from 7 mm to 7.5 mm. Columns with a diameter of 7 mm are no longer manufactured.

测定：柱直径从7 毫米变为7.5 毫米。直径为7 毫米的柱子不再生产。
Sucrose stearate (2318)

硬脂酸蔗糖酯（2318）
Assay: column diameter changed from 7 mm to 7.5 mm. Columns with a diameter of 7 mm are no longer manufactured.

测定：柱直径从7 毫米变为7.5 毫米。直径为7 毫米的柱子不再生产。
Tapentadol hydrochloride (3035)

盐酸氢可酮（3035）
Identification by IR. reference spectrum added as an alternative to chemical reference substance.

通过红外光谱鉴别。添加参考光谱作为化学对照品的替代物。
Enantiomeric purity: calculation method moved up; reporting threshold replaced by an additional system suitability test (minimum signal-to -noise ratio) to verify the sensitivity of the procedure.

对映体纯度：计算方法上移；报告阈值被额外的系统适用性测试（最小信噪比）取代，以验证该程序的灵敏度。
Tobramycin (0645)

妥布霉素（0645）
Production: the section has been deleted in accordance with the strategy to remove animal tests for histamine and depressor substances and the remainders of these tests from the European Pharmacopoeia (see Bratos M, Kolaj - Robin O, Antoni M, Charton E. Ph. Eur. testing for histamine and depressor substances using guinea - pigs and cats: the end of an era. Strategy for removal of animal tests for histamine and depressor substances and their vestiges from the Ph. Eur. Pharmeur Bio Sci Notes. 2024:12 - 26).

生产：根据从欧洲药典中去除组胺和降压物质的动物试验以及这些试验的剩余部分的策略，该部分已被删除（见Bratos M、Kolaj - Robin O、Antoni M、Charton E。欧洲药典用豚鼠和猫进行组胺和降压物质测试：一个时代的结束。从欧洲药典中去除组胺和降压物质的动物试验及其痕迹的策略。Pharmeur 生物科学笔记。2024：12 - 26）。
Trypsin (0694)胰蛋白酶（0694）
Production: a part of the section has been deleted in accordance with the strategy to remove animal tests for histamine and depressor substances and the remainders of these tests from the European Pharmacopoeia (see Bratos M, Kolaj - Robin O, Antoni M, Charton E. Ph. Eur. testing for histamine and depressor substances using guinea - pigs and cats: the end of an era. Strategy for removal of animal tests for histamine and depressor substances and their vestiges from the Ph. Eur. Pharmeur Bio Sci Notes. 2024:12 - 26).

生产：根据从欧洲药典中去除组胺和降压物质的动物试验以及这些试验的剩余部分的策略，该部分的一部分已被删除（见Bratos M、Kolaj - Robin O、Antoni M、Charton E。欧洲药典用豚鼠和猫进行组胺和降压物质测试：一个时代的结束。从欧洲药典中去除组胺和降压物质的动物试验及其痕迹的策略。Pharmeur 生物科学笔记。2024：12 - 26）。
Editorial changes have also been made throughout the monograph (French version only).

整个专论也进行了编辑更改（仅法语版本）。
Urofollitropin (0958)

尿促卵泡素（0958）
Assay: the procedure has been modified to remove the mercury - containing compound thiomersal (REACH) as an example of a suitable antimicrobial preservative.

测定：该程序已被修改，以去除含汞化合物硫柳汞（REACH）作为合适的抗菌防腐剂的一个例子。
Urokinase (0695)

尿激酶（0695）
Production: a part of the section has been deleted in accordance with the strategy to remove animal tests for histamine and depressor substances and the remainders of these tests from the European Pharmacopoeia (see Bratos M, Kolaj - Robin O, Antoni M, Charton E. Ph. Eur. testing for histamine and depressor substances using guinea - pigs and cats: the end of an era. Strategy for removal of animal tests for histamine and depressor substances and their vestiges from the Ph. Eur. Pharmeur Bio Sci Notes. 2024:12 - 26).

生产：根据从欧洲药典中去除组胺和降压物质的动物试验以及这些试验的剩余部分的策略，该部分的一部分已被删除（见Bratos M、Kolaj - Robin O、Antoni M、Charton E。欧洲药典用豚鼠和猫进行组胺和降压物质测试：一个时代的结束。从欧洲药典中去除组胺和降压物质的动物试验及其痕迹的策略。Pharmeur 生物科学笔记。2024：12 - 26）。
Editorial changes have also been made throughout the monograph.

整个专论也进行了编辑更改。
Ursodeoxycholic acid (1275)

熊去氧胆酸（1275）
Identification: TLC method description included under identification B (second identification) since the previously cross - referenced procedure for impurity C by TLC has been replaced by a new LC procedure.

鉴别：鉴别项下包含TLC 法描述B（第二种鉴别方法），因为之前通过TLC 对杂质C 的交叉引用程序已被新的液相色谱（LC）程序取代。
Impurity C: TLC changed to LC procedure covering the control of additional impurity J.

杂质C：将薄层色谱法（TLC）改为液相色谱法（LC）程序，以涵盖对额外杂质J 的控制。
Related substances: in the preparation of reference solution (a), volume expressed using fewer significant figures due to the qualitative use of this solution; reagent used to describe stationary LC phase modified; tolerance for the column temperature changed from ±1 °C to ±2 °C; quantitative style now prescribed.

有关物质：在制备对照溶液（a）时，由于该溶液用于定性，体积表示使用较少的有效数字；用于描述液相色谱固定相的试剂已修改；柱温容差从 ±1°C 变为 ±2°C；现在规定了定量方式。
Impurities: impurity J introduced.

杂质：引入了杂质J。
Zanamivir hydrate (2611)

扎那米韦水合物（2611）
Loss on drying: the test by loss on drying was reported to be inadequate to release all the water due to the crystalline structure of zanamivir; change to a micro determination method (evaporation technique) to allow a more accurate determination of the water content.

干燥失重：据报道，由于扎那米韦的晶体结构，干燥失重试验不足以释放所有水分；改为微量测定法（蒸发技术），以便更准确地测定水分含量。

 

来源：Internet

关键词： 欧洲药典