Application of Recombinant Factor C Reagent for the Detection of Bacterial Endotoxins in Pharmaceutical Products

Reference

1. 1.↵
   21 U.S.C. § 211.167 (2016).
2. 2.↵
   1. Ding J. L.,
   2. Ho B.

   Assays for Endotoxin. U.S. Patent 6645724 B1S, 1997.
3. 3.↵
   Chapters <61>, <85>, <1225>. In United States Pharmacopeia and National Formulary (USP 39-NF 34); United States Pharmacopeia Convention: Rockville, MD; 2016.
4. 4.↵
   Chapters 2.6.14 and 5.1.10. In European Pharmacopoeia 8.8; European Directorate for the Quality of Medicines & Health Care: Strasbourg, France, 2016.
5. 5.↵
   Chapter 4.01, GN13. In Japanese Pharmacopeia 16; Ministry of Health, Labour and Welfare, 2011.
6. 6.↵
   U.S. Food and Drug Administration (FDA). Guidance for Industry: Pyrogen and Endotoxins Testing: Questions and Answers; FDA: Bethesda, MD, 2012.
7. 7.↵
   Interagency Coordinating Committee on the Validation of Alternative Methods Authorization Act of 2000. Public Law 106-545, 2000.
8. 8.↵
   European Union Directive 2010/63/EU, 2010.
9. 9.↵
   1. Loverock B.,
   2. Simon B.,
   3. Burgenson A.,
   4. Baines A.,
   5. Walkersville L.

   Stimuli to the Revision Process: A Recombinant Factor C Procedure for the Detection of Gram-negative Bacterial Endotoxin. Pharmacopoeial Forum 2010, 36 (1), 321–329.

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