FDA发布Q3C残留溶剂杂质指南最终版
Q3C Impurities: Residual Solvents
FDA发布Q3C残留溶剂杂质指南最终版，就药品中的残留溶剂提出可接受量的建议，以保障患者安全。指南建议使用毒性较低的溶剂，并列出部分残留溶剂被认为毒理学可接受的水平。完整溶剂清单见配套文件Q3C — Tables and List，该清单并非穷尽，其他溶剂可在日后加入；文件编号为FDA-1997-D-0381，1997年12月定稿。
该指南以患者安全为目标，为药品中残留溶剂建议可接受量并提倡使用低毒溶剂，具体溶剂名单见配套文件。
GUIDANCE DOCUMENT
Q3C Impurities: Residual Solvents_2011 December 1997
Final
- Docket Number:
- FDA-1997-D-0381
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
The objective of this guidance is to recommend acceptable amounts for residual solvents in pharmaceuticals for the safety of the patient. The guidance recommends use of less toxic solvents and describes levels considered to be toxicologically acceptable for some residual solvents. A complete list of the solvents included in this guidance is provided in a companion document entitled Q3C — Tables and List. The list is not exhaustive, and other solvents may be used and later added to the list
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-1997-D-0381.
来源：FDA Pharmaceutical Quality Documents · fda.gov