FDA 发布 ICH Q3C 残留溶剂配套表格与清单第 4 版
Q3C—Tables and List
FDA 发布 ICH Q3C 残留溶剂指南的配套文件《Tables and List》第 4 版，标注为最终版，时间为 2018 年 8 月。该文件是 ICH Q3C《Impurities: Residual Solvents》指南的配套文件，后者就药品中残留溶剂的安全限量提出建议。FDA 就该文件开放意见提交，电子提交的案卷编号为 FDA-2013-S-0610。
该文件为 ICH Q3C 残留溶剂指南的配套表格与清单第 4 版，可用于核对药品中残留溶剂的安全限量条目。
GUIDANCE DOCUMENT
Q3C Tables and List Rev. 4 August 2018
Final
- Issued by:
-
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research
This is the companion document for the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidance for industry Q3C Impurities: Residual Solvents, which makes recommendations as to what amounts of residual solvents are considered safe in pharmaceuticals.
Companion document to Q3C Impurities: Residual Solvents
Submit Comments
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.
来源：FDA Pharmaceutical Quality Documents · fda.gov