需进行研究,可不定入质量标准,产品放行可不进行检测,具体参考的相关要求如下:
1. 溶解度控制要求:
药典 | 控制要求 | 解读 |
ChP | 凡例:溶解度是药品的一种物理性质。各品种项下选用的部分溶剂及其在该溶剂中的溶解性能,可供精制或制备溶液时参考;对在特定溶剂中的溶解性能需作质量控制时,在该品种检查项下另作具体规定。 | 该项目为参考项目,特定溶剂溶解性能需作质量控制时,在该品种检查项下另作具体规定,同时在2023.11发布的《中国药典》药用辅料标准性状项下溶解度调整意见的函中也明确了此项内容,但是关于原料药的控制是否也按照此函的要求进行,目前没有明确的后续规定。 |
关于征求《中国药典》药用辅料标准性状项下溶解度调整意见的函 一、鉴于性状项下溶解度为参考信息,将《中国药典》药用辅料标准性状项下溶解度的内容调整至标准文末“注”中,与《中国药典》2020年版对原性状项下不宜检测的项目(如引湿、潮解、腐蚀、风化等)的调整方式保持一致。 二、将现版《中国药典》四部凡例第十五条中关于药用辅料性状项下溶解度的相关表述(即:溶解度是一种物理性质。各品种项下选用的部分溶剂及其在该溶剂中的溶解性能,可供精制或制备溶液时参考;对在特定溶剂中的溶解性能需作质量控制时,在该品种检查项下另作具体规定。)调整至《国家药用辅料标准编写细则》的“注”项下进行说明。 此方案如经审议确定,将在《中国药典》2025年版中统一修改。 | ||
USP | General notices:5.30. Description and solubility Only where a quantitative solubility test is given in a monograph and is designated as such is it a test for purity. A monograph may include information regarding the article's description. Information about an article's description and solubility" also is provided in the reference table Description and Relative Solubility of USP and NF Articles. The reference table merely denotes the properties of articles that comply with monograph standards. The reference table is intended primarily for those who use, prepare, and dispense drugs and/or related articles. Although the information provided in monographs and the information in the reference table may indirectly assist in the preliminary evaluation of an article, it is not intended to serve as a standard or test for purity. | 美国药典将溶解度项目放在了参考信息表中,特定溶剂做质量控制要求时将会在个论中列出,溶解度项目仅作为参考信息,不需要设立标准或作为纯度考察的一个项目,同时关于该项内容在USP FAQs中进行了索引。 |
USP FAQs 4. Must the specifications described in the Description and Solubility section of the USP-NF be met? (See also General Notices, section 5.30.) 5.30. Description and Solubility Only where a quantitative solubility test is given in a monograph and is designated as such is it a test for purity. A monograph may include information regarding the article's description. Information about an article's "description and solubility" also is provided in the reference table Description and Relative Solubility of USP and NF Articles. The reference table merely denotes the properties of articles that comply with monograph standards. The reference table is intended primarily for those who use, prepare, and dispense drugs and/or related articles. Although the information provided in monographs and the information in the reference table may indirectly assist in the preliminary evaluation of an article, it is not intended to serve as standard or test for purity. | ||
Ph. Eur. | General notices: 1.5.1.7 Characters The statements in the Characters section do not constitute. Eur. requirements and are given for information only. Hygroscopicity, crystallinity, solubility. See general chapter 5.11. Characters section in monographs. | 性状项下(包括溶解度)的描述仅作为参考信息并不构成欧洲药典的要求。 |
JP | General notices 5. The JP Drugs are to be tested according to the provisions given in the pertinent monographs, General Notices, General Rules for Crude Drugs, General Rules for Preparations, and General Tests for their conformity to the Japanese Pharmacopoeia. However, the headings of "Description", and in addition "Con-trainers and storage", and "Shelf life", in the mono-graphs on preparations are given for information, and should not be taken as indicating standards for conformity. Nevertheless, Containers under "Containers and storage", in the monograph on preparations con-training crude drugs as main active ingredients are the standards for conformity. | 性状项下仅作为参考信息,不作为药典符合性的检测标准。 |
总结:
1、美国药典将溶解度项目放在了参考信息表中(除特定溶剂下溶解度定量控制外),其余药典溶解度在产品的个论项下。
2、美国药典、欧洲药典、日本药典均明确规定溶解度项目为参考项目,不作为质量控制要求。
3、中国药典凡例中也规定了溶解度作为参考,但未明确可不作为质量标准控制,同时在2023.11发布的《中国药典》药用辅料标准性状项下溶解度调整意见的函中也明确了此项内容,但是关于原料药的控制是否也按照此函的要求进行,目前没有明确的后续规定。
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