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1、人用药品注册技术要求国际协调会ICH 三方指导文件新原料药和制剂的稳定性试验Q1A(R2)现第四版2003年2月6日制定Q1A(R2)文件历程原编码历史日 期新编码2005年11月Q1 在第二阶段被指导委员会批准并公开发布征求意见1992年9月16日Q1 Q1A 在第四阶段被指导委员会批准并推荐给ICH 三方当局征求意见。Q1A从命名为 Q1A 1993年10月27日Q1A Q1A(R)第一次修订文本得到指导委员会批准并公开发布征求指导意见1999年10月7日Q1A(R1)Q1A(R)在第四阶段第一版被指导委员会批准并推荐给ICH 三方当局征求意见。2000年11月8日Q1A(R1)现第四版Q
2、1A(R2)第四阶段第二版直接被指导委员会批准，没有公开发布征求意见。此文本包含了因采纳Q1F（和气候带注册申请的稳定性数据包）所引起的改变，并推荐给ICH三方当局采纳。2003年2月6日Q1A(R2)文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 Z
3、Z4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F
4、6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文
5、档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT
6、3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H
7、6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP
8、10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2
9、P9Z9 ZZ4Z10F6L9B1新原料药和制剂的稳定性试验Q1A(R)修订说明本修订的目的为了明确由于采用了ICH Q1F“在气候带和注册申请的稳定性数据包”而使 Q1A(R)而产生的变更。这些变更如下：1.在下面章节中将中间储存条件从温度30 2/相对湿度 60%5%修改为温度30 2/相对湿度 65%5%：2.1.7.1 原料药-储存条件-一般情况2.2.7.1 制剂-储存条件-一般情况2.2.7.3 在半渗透性容器中包装的制剂3 术语-“中间试验”2.在下面章节中可以使用温度30 2/相对湿度 65%5%替代温度 25 2/相对湿度60%5%作为长期稳定性试验的条件：2.1.7.1 原
10、料药-储存条件-一般情况2.2.7.1 制剂-储存条件-一般情况3.在温度 25 2/相对湿度 40%5%的基础上增加了温度30 2/相对湿度 35%5%作为长期稳定性试验条件，并且在后面的章节中包括了失水比率相关举例的相关情况：2.2.7.3 在半透性容器中包装的制剂在试验阶段中间将中间将储存条件从温度30 2/相对湿度 60%5%调整为温度30 2/相对湿度 65%5%是可以的，但相应的储存条件和调整的日期要在注册申报资料中清楚地说明和列出。如果适用的话建议ICH 三方在公布和执行此修订指南三年后，注册申请资料中完整的试验能够包含在中间储存条件，即温度30 2/相对湿度 65%5%下的实验
11、资料。文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编
12、码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V
13、7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W
14、6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10
15、P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9
16、Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4
17、Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS1.INTRODUCTION 1.1.Objective
18、s of the Guideline The following guideline is a revised version of the ICH Q1A guideline and defines the stability data package for a new drug substance or drug product that is sufficient for a registration application within the three regions of the EC,Japan,and the United States.It does not seek n
19、ecessarily to cover the testing for registration in or export to other areas of the world.The guideline seeks to exemplify the core stability data package for new drug substances and products,but leaves sufficient flexibility to encompass the variety of different practical situations that may be enc
20、ountered due to specific scientific considerations and characteristics of the materials being evaluated.Alternative approaches can be used when there are scientifically justifiable reasons.1.2.Scope of the Guideline The guideline addresses the information to be submitted in registration applications
21、 for new molecular entities and associated drug products.This guideline does not currently seek to cover the information to be submitted for abbreviated or abridged applications,variations,clinical trial applications,etc.Specific details of the sampling and testing for particular dosage forms in the
22、ir proposed container closures are not covered in this guideline.新原料药和制剂稳定性试验1.导言1.1.目的下述的指导原则是ICH Q1A 的修订版本，并且它为新原料药和制剂在欧洲、日本、美国三个地区注册所需要的稳定性资料做出规定要求。它并不涵盖世界其它地区或出口到这些地区的注册要求。本指导原则试图去例证新原料药和制剂的核心稳定性数据，但是留有足够的弹性空间去适应由于特殊的科学考虑和被评估物质特殊性质而导致的各种不同的具体情况。在有科学依据和理由的情况下也可以采用替代的方案。1.2.范围本指导文件所针对的是新分子实体及其相关制剂
23、注册时需提交的信息。此指导文件并不寻求为简略或简化申请，变更申请和临床试验申请提供指导。在特定的密闭系统中的特殊剂型的抽样和检验的详细指导不包括在此指导文件的范文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7
24、D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6
25、 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P
26、8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z
27、9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z
28、10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9
29、B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1Furt
30、her guidance on new dosage forms and on biotechnological/biological products can be found in ICH guidelines Q1C and Q5C,respectively.1.3.General Principles The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influe
31、nce of a variety of environmental factors such as temperature,humidity,and light,and to establish a re-test period for the drug substance or a shelf life for the drug product and recommended storage conditions.The choice of test conditions defined in this guideline is based on an analysis of the eff
32、ects of climatic conditions in the three regions of the EC,Japan and the United States.The mean kinetic temperature in any part of the world can be derived from climatic data,and the world can be divided into four climatic zones,I-IV.This guideline addresses climatic zones I and II.The principle has
33、 been established that stability information generated in any one of the three regions of the EC,Japan and the United States would be mutually acceptable to the other two regions,provided the information is consistent with this guideline and the labeling is in accord with national/regional requireme
34、nts.2.GUIDELINES 2.1.Drug Substance 2.1.1.General Information on the stability of the drug 围中。有关新剂型和生物技术/生物制品进一步指导请分别参考ICH Q1C 和 Q5C。1.3 通则稳定性试验的目的是为原料药或制剂的各种环境因素，如温度、湿度和光照等，影响下质量在如何随时间变化提供证据，从而为原料药制定复检期或为制剂制定有效期，和推荐的贮存条件。本指导文件中的试验选择是基于对欧洲、日本、美国这三个地区的气候条件影响分析制定的。世界任何一个地带的平均动力学温度都可以从气象数据中获得，世界被分为四个气候
35、带，本指导文件描述的是和气候带的情况。一个通用原则已经被确立，即欧洲、日本、美国这三个地区中的任一地区的稳定性资料都应被其他两个地区所互相接受，提供的资料应与本指导文件相一致，标签规格应与各自国家/地区的要求相一致。文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J
36、2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9
37、ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10
38、F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1
39、文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:C
40、T3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1
41、H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 H
42、P10P8J2P9Z9 ZZ4Z10F6L9B1substance is an integral part of the systematic approach to stability evaluation.2.1.2.Stress Testing Stress testing of the drug substance can help identify the likely degradation products,which can in turn help establish the degradation pathways and the intrinsic stability o
43、f the molecule and validate the stability indicating power of the analytical procedures used.The nature of the stress testing will depend on the individual drug substance and the type of drug product involved.Stress testing is likely to be carried out on a single batch of the drug substance.It shoul
44、d include the effect of temperatures(in 10C increments(e.g.,50C,60 C,etc.)above that for accelerated testing),humidity(e.g.,75%RH or greater)where appropriate,oxidation,and photolysis on the drug substance.The testing should also evaluate the susceptibility of the drug substance to hydrolysis across
45、 a wide range of pH values when in solution or suspension.Photostability testing should be an integral part of stress testing.The standard conditions for photostability testing are described in ICH Q1B.Examining degradation products under stress conditions is useful in establishing degradation pathw
46、ays and developing and validating suitable analytical procedures.However,it may not be necessary to examine specifically for certain degradation products if it has been demonstrated that they are not formed under accelerated or long term storage conditions.Results from these studies will form an int
47、egral part of the information provided to regulatory authorities.2.指导文件2.1 原料药2.1.1 概述原料药的稳定性资料是系统评估稳定性的一个主要组成部分。2.1.2 影响因素试验原料药的影响因素试验能帮助确定可能的降解物，这些降解物能依次帮忙确立降解路径，确立分子的内在稳定性和确定验证方法的稳定性指示能力，影响因素试验的本质取决于具体的原料药及所涉及的制剂类别。影响因素试验可以在一个批次的原料药中展开研究，它包括温度的影响（以10为增量单位，如50，60等，高于加速试验的温度），湿度的影响（例如75%相对湿度或更高），适当
48、情况下氧化和光照的影响。当在溶液中或悬浮液中时，试验也可以通过一定范围的pH 值评估原料药水解作用的敏感性。光稳定性试验是影响因素试验的一个主要组成部分。光稳定性试验的标准条件在ICH Q1B 中描述。在影响因素试验条件下检查降解产物能有帮助确立降解路径和开发验证合适的分析方法。但是，对于已知的并且经证明在加速和长期试验条件下没有形成的降解产物没有必要再做特别的检查。这些试验的结果是向监管部门提交资料的组成部分。文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3
49、V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6
50、W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP10P8J2P9Z9 ZZ4Z10F6L9B1文档编码:CT3V7D1H6W6 HP1