FDA 发布美国上市药品残留溶剂行业指南最终版（FDA-2008-D-0413）
Residual Solvents in Drug Products Marketed in the United States
FDA 药品评价与研究中心（CDER）发布《美国上市药品残留溶剂》行业指南最终版，案卷编号为 FDA-2008-D-0413，标注为 2009 年 11 月定稿。该指南旨在帮助制造商回应美国药典（USP）对在美国上市药品中残留溶剂控制的要求，并就相关事项提出建议。文件同时说明可随时在线或书面提交意见，书面意见需注明该案卷编号。
GUIDANCE DOCUMENT
Residual Solvents in Drug Products Marketed in the United States Guidance for Industry November 2009
Final
- Docket Number:
- FDA-2008-D-0413
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
This guidance is intended to assist manufacturers in responding to the issuance of the United States Pharmacopeia (USP) requirement; for the control of residual solvents in drug products marketed in the United States. Specifically, this guidance makes recommendations on the following
Submit Comments
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
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 written comments should be identified with this document's docket number: FDA-2008-D-0413.
来源：FDA Pharmaceutical Quality Documents · fda.gov