嘉峪检测网 2025-05-14 13:01
导读：本文提议修订美国药典（USP）中受控室温（CRT）的定义，使其与日本药局方（JP）、欧洲药典（EP）和世界卫生组织（WHO）推荐的室温范围保持一致。
近日，USP在线论坛刊出文章建议将USP中受控室温（20°–25°C）调整至15°C–25°C。如下：
Aligning Room Temperature Standards for Pharmaceuticals—A Sustainable Approach
统一药品室温标准 —— 一种可持续的方法
ABSTRACT
This article proposes a revision to the United States Pharmacopeia (USP) definition of controlled room temperature (CRT) to align with the room temperature ranges recommended by the Japanese Pharmacopoeia (JP), European Pharmacopoeia (EP), and World Health Organization (WHO). The current discrepancy between USP’s CRT definition (20°–25°C) and the JP, EP, and WHO standards (15°–25°C) can lead to inconsistencies in drug storage practices and increased energy consumption. By aligning these standards, the pharmaceutical industry can reduce energy costs, minimize carbon emissions, and enhance global consistency in storage practices. This proposal emphasizes the importance of harmonization in promoting environmental sustainability, improving energy efficiency, and ensuring the safety and stability of pharmaceutical products. The article invites stakeholders to engage in discussions on the feasibility and benefits of this change, highlighting its potential to support global environmental goals and create a more sustainable future for the pharmaceutical industry.
摘要：本文提议修订美国药典（USP）中受控室温（CRT）的定义，使其与日本药局方（JP）、欧洲药典（EP）和世界卫生组织（WHO）推荐的室温范围保持一致。目前 USP 的 CRT 定义（20°–25°C）与 JP、EP 和 WHO 标准（15°–25°C）之间的差异，可能导致药品储存实践不一致，并增加能源消耗。通过统一这些标准，制药行业可以降低能源成本，减少碳排放，并提高全球储存实践的一致性。该提议强调了协调统一在促进环境可持续性、提高能源效率以及确保药品安全性和稳定性方面的重要性。本文邀请利益相关者就这一变更的可行性和益处展开讨论，突显其在支持全球环境目标以及为制药行业创造更可持续未来方面的潜力。
OBJECTIVE
The objective of this proposal is to discuss a potential revision to the United States Pharmacopeia (USP) definition of controlled room temperature (CRT) to align with the room temperature ranges recommended by the Japanese Pharmacopoeia (JP), European Pharmacopoeia (EP), and World Health Organization (WHO). By aligning these standards, we seek to reduce energy consumption during winter months, minimize carbon emissions, and contribute to a more sustainable pharmaceutical industry.
目标：本提议的目的是探讨对美国药典（USP）中受控室温（CRT）定义进行潜在修订的可能性，以使其与日本药局方（JP）、欧洲药典（EP）和世界卫生组织（WHO）推荐的室温范围保持一致。通过统一这些标准，我们旨在减少冬季的能源消耗，尽量减少碳排放，并为制药行业实现更可持续的发展做出贡献。
BACKGROUND
Pharmaceutical products are essential in maintaining public health, and consistent storage conditions are critical to ensuring the quality, safety, and efficacy of pharmaceutical products. Currently, there is a discrepancy between the USP's CRT definition (20°–25°C, with excursions permitted within the range of 15°–30°C) and the room temperature ranges defined by the JP, EP, and WHO (15°–25°C). This misalignment can lead to inconsistencies in drug storage practices and increased energy consumption.
背景：药品对于维护公众健康至关重要，而一致的储存条件对于确保药品的质量、安全性和有效性至关重要。目前，USP 的 CRT 定义（20°–25°C，允许在 15°–30°C 范围内波动）与 JP、EP 和 WHO 定义的室温范围（15°–25°C）存在差异。这种不一致可能会导致药品储存方面的差异，以及能源消耗的增加。
This Stimuli article discusses the potential benefits and implications of revising USP's CRT definition to align with the JP, EP, and WHO. By doing so, we hope to improve energy efficiency, reduce environmental impact, and facilitate global consistency in pharmaceutical storage practices.
本文讨论了将 USP 的 CRT 定义修订为与 JP、EP 和 WHO 一致的潜在益处和影响。通过这样做，我们希望提高能源效率，减少对环境的影响，并促进全球药品储存实践的一致性。
History of USP's Definition of Controlled Room Temperature
The United States Pharmacopeia (USP) has a long history of defining storage conditions to ensure the stability and efficacy of pharmaceutical products. The controlled room temperature (CRT) definition first appeared in 1970 in USP 18: “Controlled Room Temperature is a temperature maintained thermostatically between 15° and 30°C (59° and 86°F)” (1). In 1990, USP 22–NF 17 Supplement 9, the CRT definition was revised to allow for temperature excursions and to update the temperature range to 20° to 25°C (68° to 77°F):
USP 受控室温定义的历史：美国药典（USP）长期以来一直致力于定义储存条件，以确保药品的稳定性和有效性。受控室温（CRT）的定义最早于 1970 年出现在 USP 18 中：“受控室温是指通过恒温维持在 15°C 至 30°C（59°F 至 86°F）之间的温度”(1)。1990 年，USP 22 - NF 17 补编 9 对 CRT 定义进行了修订，允许温度波动，并将温度范围更新为 20°C 至 25°C（68°F 至 77°F）：
"Controlled Room Temperature—A temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°C; and that allows for excursions between 15° and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses. Articles may be labeled for storage at 'controlled room temperature' or at 'up to 25°C,' or other wording based on the same mean kinetic temperature. The mean kinetic temperature is a calculated value that may be used as an isothermal storage temperature that simulates the nonisothermal effects of storage temperature variations. (See also Stability under Pharmaceutical Dosage Forms 〈1151〉.) An article for which storage at controlled room temperature is directed may, alternatively, be stored in a cool place, unless otherwise specified in the individual monograph or on the label" (2).
“受控室温 —— 通过恒温维持的温度，涵盖通常和习惯的工作环境温度 20°C 至 25°C（68°F 至 77°F）；计算得出的平均动力学温度不超过 25°C；并允许在药房、医院和仓库中常见的 15°C 至 30°C（59°F 至 86°F）之间波动。物品可以标记为在‘受控室温’或‘最高 25°C’或基于相同平均动力学温度的其他措辞下储存。平均动力学温度是一个计算值，可作为模拟储存温度变化的非等温效应的等温储存温度。（另见药品剂型项下的稳定性〈1151〉）。除非在各论或标签中另有规定，指示在受控室温下储存的物品，也可储存在阴凉处”(2)。
This revision of the CRT definition coincided with updates to Pharmaceutical Dosage Forms〈1151〉, which included an increased emphasis on product stability and the introduction of mean kinetic temperature (MKT). The shift reflected a more nuanced understanding of how temperature fluctuations during storage impact the degradation of pharmaceutical products, leading to better alignment of storage conditions with stability requirements and ensuring the integrity and efficacy of products throughout their shelf life. The incorporation of MKT into the CRT definition underscores the importance of controlling storage environments, accounting for temperature excursions, and providing precise labeling guidance, particularly for products distributed internationally (3).
CRT 定义的此次修订与药品剂型〈1151〉的更新同步进行，后者更加注重产品稳定性，并引入了平均动力学温度（MKT）。这一转变反映了对储存过程中温度波动如何影响药品降解有了更细致的理解，使储存条件能更好地与稳定性要求相匹配，确保产品在整个保质期内的完整性和有效性。将 MKT 纳入 CRT 定义，突显了控制储存环境、考虑温度波动以及提供精确标签指导的重要性，特别是对于国际分销的产品 (3)。
Current Definitions and Examples
当前定义及示例
Japanese Pharmacopoeia (JP)
Cold: 1°–15°C
Standard temperature: 20°C
Room temperature: 15°–25°C (4)
Example: In Japan, certain vaccines and biologics are required to be stored at room temperature (15°–25°C), aligning with JP’s broader range. This allows for more flexibility during colder months (5).
日本药局方（JP）
冷藏：1°C–15°C
标准温度：20°C
室温：15°C–25°C (4)
示例：在日本，某些疫苗和生物制品需在室温（15°C–25°C）下储存，符合 JP 更宽泛的温度范围。这在较冷的月份提供了更大的灵活性 (5)。
European Pharmacopoeia (EP)
Room temperature: 15°–25°C (6)
欧洲药典（EP）
室温：15°C–25°C (6)
World Health Organization (WHO)
Room temperature: 15°–25°C (7)
世界卫生组织（WHO）
室温：15°C–25°C (7)
International Council for Harmonisation (ICH)
No specific definition, but harmonization aligns with ICH principles (8)
国际人用药品注册技术协调会（ICH）
无具体定义，但协调统一符合 ICH 原则 (8)
United States Pharmacopeia (USP)
Controlled room temperature: 20°–25°C, with excursions permitted within the range of 15°–30°C (9)
美国药典（USP）
受控室温：20°C–25°C，允许在 15°C–30°C 范围内波动 (9)
Proposed Change
The proposal suggests revising the USP CRT definition for drug storage and transportation (i.e., distribution) from the current range of 20°–25°C.
提议的变更：该提议建议将 USP 中用于药品储存和运输（即分销）的 CRT 定义，从目前的 20°C–25°C 范围进行修订。
Rationale
理由
Energy costs and efficiency—Maintaining a controlled room temperature range of 20°C–25°C incurs significant energy costs, especially in regions with colder climates. For example, in the northern United States, where winter temperatures often drop below 0°C, maintaining the higher range requires extensive heating, which in turn increases energy consumption and costs.
能源成本和效率：维持 20°C–25°C 的受控室温范围会产生高昂的能源成本，尤其是在气候较冷的地区。例如，在美国北部，冬季气温经常降至 0°C 以下，维持较高的温度范围需要大量供暖，这反过来又增加了能源消耗和成本。
Environmental impact—Harmonizing room temperature standards can lead to reduced carbon emissions due to decreased energy usage. Aligning temperature recommendations contributes to global efforts to combat climate change, making the pharmaceutical industry more environmentally responsible. As we proceed through the 21st century, the importance of environmental sustainability is becoming more important. Reducing our carbon footprint and conserving energy are critical first steps towards a healthier planet (10).
环境影响：统一室温标准可因能源使用减少而降低碳排放。统一温度建议有助于全球应对气候变化的努力，使制药行业在环境方面更具责任感。随着我们步入 21 世纪，环境可持续性的重要性日益凸显。减少碳足迹和节约能源是迈向更健康地球的关键第一步 (10)。
Global consistency—Harmonization simplifies international trade and distribution. Manufacturers can produce medicines with consistent storage requirements, facilitating smoother global supply chains and reducing logistical complexities. This consistency is particularly important in an era when global supply chains are increasingly interconnected and interdependent (11).
全球一致性：协调统一可简化国际贸易和分销。制造商可以生产具有一致储存要求的药品，促进更顺畅的全球供应链，并降低物流复杂性。在全球供应链日益相互关联和相互依存的时代，这种一致性尤为重要 (11)。
Safety and stability—Scientific evidence supports that drug products remain stable within the proposed range of 15°–25°C. Studies have shown that lowering the temperature range does not significantly accelerate product degradation, ensuring the continued safety and efficacy of pharmaceuticals (12).
安全性和稳定性：科学证据支持药品在提议的 15°C–25°C 范围内保持稳定。研究表明，降低温度范围不会显著加速产品降解，确保了药品的持续安全性和有效性 (12)。
Product wastage—Inconsistent temperature standards can lead to scenarios where pharmaceutical products are deemed unusable due to noncompliance with storage requirements. For instance, a product stored at 18°C may be acceptable in one region but not in another, leading to unnecessary disposal of otherwise safe and effective medications. This not only results in financial losses but also contributes to environmental waste (13).
产品浪费：不一致的温度标准可能导致药品因不符合储存要求而被视为不可用。例如，在一个地区储存在 18°C 的产品可能在另一个地区不被接受，导致原本安全有效的药物被不必要地丢弃。这不仅造成经济损失，还会造成环境浪费 (13)。
Discussion and Feedback
USP invites industry stakeholders to engage in a discussion about this proposed change. Your feedback is crucial in assessing the feasibility, benefits, and potential challenges of harmonizing the USP CRT definition. By collaborating, we can ensure that any revisions made to the standard are in the best interests of both the industry and the environment.
讨论与反馈：USP 邀请行业利益相关者就这一提议的变更展开讨论。您的反馈对于评估统一 USP CRT 定义的可行性、益处和潜在挑战至关重要。通过合作，我们可以确保对标准所做的任何修订都符合行业和环境的最佳利益。
CONCLUSION
Harmonizing USP’s CRT temperature range to 15°–25°C promotes energy efficiency, environmental responsibility, and product safety. This proposal serves as a starting point, and further discussions and collaboration among regulatory bodies, industry experts, and stakeholders are essential. Such a change will not only help enhance global consistency in drug storage practices but also support broader environmental goals. The benefits of reduced energy consumption and lower carbon emissions align with global efforts to combat climate change, making this harmonization a pivotal step toward a more sustainable future for the pharmaceutical industry. We look forward to your input and collaboration on this important initiative.
结论：将 USP 的 CRT 温度范围统一为 15°C–25°C，有助于提高能源效率、增强环境责任感并保障产品安全。本提议作为一个起点，监管机构、行业专家和利益相关者之间进一步的讨论和合作至关重要。这样的变更不仅有助于提高全球药品储存实践的一致性，还支持更广泛的环境目标。降低能源消耗和减少碳排放的益处与全球应对气候变化的努力相一致，使这种协调统一成为制药行业迈向更可持续未来的关键一步。我们期待您对这一重要倡议的投入和合作。
DISCLAIMER
Stimuli articles do not necessarily reflect the policies of the United States Pharmacopeial Convention or the USP Council of Experts.
免责声明：“刺激因素” 文章不一定反映美国药典公约或 USP 专家委员会的政策。
[Note—The authors did not declare any perceived or actual conflicts of interest related to the subject matter of this Stimuli article. The views presented in this article do not necessarily reflect those of the organizations for which the authors work. No official support or endorsement by these organizations is intended or should be inferred.]
[注 - 作者未声明与本文主题相关的任何已察觉或实际的利益冲突。本文所表达的观点不一定代表作者所在组织的观点。这些组织无意提供官方支持或背书，也不应被推断有此意图。]
REFERENCES
参考文献
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United States Pharmacopeia. "Controlled room temperature" as defined under Preservation, Packaging, Storage, and Labeling in General Notices. In: USP 22–NF 17, Supplement 9; 1990.
United States Pharmacopeia. Pharmaceutical Dosage Forms 〈1151〉. In: USP 22–NF 17, Supplement 9; 1990.
Pharmaceuticals and Medical Devices Agency. General Notices. In: Japanese Pharmacopeia 18th Edition; 2021.
Ministry of Health, Labour and Welfare of Japan (MHLW). Storage and Handling of Pharmaceuticals; 2019.
European Directorate for the Quality of Medicines & HealthCare (EDQM). General Notices. In: European Pharmacopoeia 11th Edition; 2023.
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International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Q1A(R2): Stability Testing of New Drug Substances and Products. 2003. https://www.ich.org/page/quality-guidelines.
United States Pharmacopeia. Packaging and Storage Requirements 〈659〉. In: USP–NF; 2024.
Intergovernmental Panel on Climate Change (IPCC). Climate Change 2021: The Physical Science Basis; 2021. https://www.ipcc.ch/report/ar6/wg1/.
United Nations Conference on Trade and Development. Global Supply Chains: Trade and Economic Policies for Developing Countries. Policy Issues in International Trade and Commodities Study Series No. 55. United Nations; 2013.
World Health Organization (WHO). WHO guidelines on stability testing of active pharmaceutical ingredients and finished pharmaceutical products. Annex 10. WHO Technical Report Series, No. 1010; 2020. https://www.who.int/publications/m/item/trs1010-annex10.
World Health Organization (WHO). WHO Global Surveillance and Monitoring System for Substandard and Falsified Medical Products; 2017. https://www.who.int/publications/i/item/9789241513425.
来源：Internet
