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The FDA expects an assessment to be performed for purchased laboratory reagents without expiry date indicated by the manufacturer.For example, literature review of that specific chemical's or chemical family's stability may be acceptable to determine an appropriate "use by" or expiry date.Inorganic Ventures can state with certainty that there are no chemical stability problems that have not been solved.Number 1 above has been eliminated in our facility.Inorganic Ventures manufactures single-element standards to be chemically stable .Our chemists have been checking and testing standards for almost 20 years.

If this information is not stated in the text in a USP monograph for the particular solution, buffer, etc., then it is up to your lab to define this frequency.Procedures for any in-house prepared laboratory solution should include the determined stability timeframe, and should instruct that these solutions be labeled with the appropriately determined "use by" or expiration date upon preparation and discarded upon expiration.We are looking to overhaul our chemical management procedures and I am curious as to the methods used by other laboratories out there in regards to assigning expiration dates for chemicals and materials where the manufacturer does not list an expiration date on the bottle or on the certificate of analysis.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.This decision is made based on the stability of the solution, its intended use and storage conditions.