Expiration dating for laboratory reagents and solutions Live streaming cams no sign up
These requirements also apply for API manufacturers (APIs according to ICH Q7) and their laboratories.
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According to ICH Q2B, stability of analytical solutions is a typical method variation that should be assessed during "Robustness testings" during validation of an analytical method.
The resulting "use by" or expiry dates should be documented according to an internal SOP.
The FDA has published a Q&A document entitled "How does the FDA interpret the regulations (21 CFR Part 211) regarding the establishment of expiry dating for chemicals, reagents, solutions, and solvents? "Reagents, and standard solutions" - referenced in c GMP's paragraph 211.194 - are actually meant, including laboratory chemicals like solvents and mobile phases, dry chemicals like salts or primary standards and solutions like buffers, acids and bases, whether purchased or self-prepared in the laboratory.
If the manufacturer suggests an expiry date, that date should be followed.
Most of the companies that we purchase chemicals from (I.e.
EMD, Avantor and Fisher) state that there is a 5 year shelf life on all of their chemicals when no expiration date is listed on the bottle of certificate of analysis.
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