The purpose of this Guideline is to outline the requirements in the expiration dating of all analytical reagents and solutions prepared from these reagents. Recommendations are also included on how to achieve compliance. 2. Scope and Applicability. This Guideline is applicable to all manufacturing Operations sites. J. M. F. Nogueira. P. Serôdio. Determination of the expiration date of chemical solutions. Introduction. The stability requirements for analytical laboratories de- mands careful control of the expiration date of chemi- cals, reagents and solutions. The use of deteriorated or expired chemical solutions affects the validity of analyti-. 年8月11日 Question: How does the FDA interpret the regulations (21 CFR Part ) regarding the establishment of expiry dating for chemicals, reagents, solutions, and solvents? Answer: Laboratory “reagents, and standard solutions,” as referenced in the CGMP regulations at , includes laboratory chemicals.
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