FDA 发布《热原与内毒素检测：问答》行业指南最终版
Pyrogen and Endotoxins Testing: Questions and Answers
FDA 发布《热原与内毒素检测：问答》行业指南，就 USP <85>、USP <161> 和 AAMI ST72:2002/R2010 的检测建议与接受标准说明其当前看法。该指南面向生物制品、药品和医疗器械企业，并提及凝胶法、光度法和动力学检测方法的基本原理。文件为最终版修订指南，可通过案卷编号 FDA-2013-S-0610 提交意见。
该指南汇总 FDA 对 USP <85>、USP <161> 与 AAMI ST72 中内毒素和热原检测建议及接受标准的当前看法，便于对照现有检测方法。
GUIDANCE DOCUMENT
Pyrogen and Endotoxins Testing: Questions and Answers Guidance for Industry March 2026
Final Level 2 Revised Guidance
- Issued by:
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Guidance Issuing Office
Center for Veterinary Medicine
Human Foods Program
Center for Drug Evaluation and Research
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research
This guidance provides recommendations for biological product, drug, and device firms on FDA’s current thinking concerning the testing recommendations and acceptance criteria in the United States Pharmacopeia (USP) Chapter <85> “Bacterial Endotoxins Test”, USP Chapter <161> “Medical Devices ‒ Bacterial Endotoxin and Pyrogen Tests”, and the Association for the Advancement of Medical Instrumentation (AAMI) ST72:2002/R2010, Bacterial Endotoxins—Test Methodologies, Routine Monitoring, and Alternatives to Batch Testing (AAMI ST72). These three documents describe the fundamental principles of the gel clot, photometric, and kinetic test methods, and recommend that appropriate components and finished products be tested for the presence of pyrogens and endotoxins.
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