ICH Q3D(R2) Guideline for Elemental Impurities is a quality guideline for the control of elemental impurities in new drug products (medicinal products), and it establishes Permitted Daily Exposures (PDEs) for 24 Elemental Impurities (EIs) for drug products administered by the oral, parenteral and inhalation routes of administration.

2002年1月8日 · This document provides guidance on the content and qualification of impurities in new drug substances for registration applications. It applies to drug substances produced by chemical syntheses and not previously registered in a region or Member State. It covers chemistry and safety aspects of impurities in new drug substances.

proposed commercial process, as well as the results of stress testing (see ICH Guideline Q1A on Stability) used to identify potential impurities arising during storage. The impurity profile of the drug substance batches intended for marketing should be compared with those used in development, and any differences discussed.

溶剂是在新原料药合成过程中用于制备溶液或混悬液的有机或无机液体，由于他们一般具有已知毒性，故较易选择控制方法（见ICH指导原则Q3C残留溶剂项下）。 不包括在本文件中的杂质为：⑴外源性污染物：不应该存在于新原料药中，可以用GMP来控制的；⑵多晶型；⑶对映异构体杂质。 3. 杂质报告和控制的合理性. 申报者应对新原料药在合成、精制和储存过程中最可能产生的那些实际存在的和潜在的杂质进行综述。 该综述应建立在对合成所涉及的化学反应、由原材料 …

Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 17 July 1997, this Guideline is recommended for adoption to the three regulatory parties to ICH 1. INTRODUCTION The objective of this guideline is to recommend acceptable amounts for residual solvents in pharmaceuticals for the safety of the patient.

pharmaceutical quality perspective and other guidelines should be consulted (e.g., ICH Q3A). This guideline presents a process to assess and control elemental impurities in the drug product using the principles of risk management as described in ICH Q9. This process

q3d作为ich 质量指南的重要部分，是中国化学创新药走向国际市场必须符合的硬性条件，同时也提高了国内化学药物申报的质量门槛。 无论是中国制药企业还是监管部门，根据ICH Q3D的不同元素PDE值和不同服药途径，建立或评审原辅料或药物成品的元素限度，在 ...

This document provides guidance for registration applications on the content and qualification of impurities in new drug products produced from chemically synthesised new drug substances not previously registered in a region or member state.

2003年1月8日 · This document provides guidance on the content and qualification of impurities in new drug products for registration applications. It applies to drug products produced from chemically synthesised new drug substances not previously …

ICHQ3指导原则旨在研发及注册申报时，对杂质研究的内容和限度确定提供指导。 ICH Q3A指导原则为ICH杂质研究的基本准则，该指导原则将杂质分为有机杂质（与工艺和药物结构有关）、无机杂质和残留杂质。 Q3B指导原则是Q3A的补充，这两个指导原则主要是对原料药或制剂中的有机杂质进行描述 [1,2]。 有机杂质通常在原料药或制剂的生产过程或储存期间产生，包括起始物料、副产物、中间体、降解产物、试剂、配体、催化剂等。 Q3C指导原则主要针对的是原料药或制 …