Expiration dating for laboratory reagents and solutions Freemontreal mature dating
The finished product reserve samples are maintained for one year past their expiration date.The raw material reserve samples must be maintained one year past the expiration of the last finished product they were used in.The expiration date of the reagent should be readily apparent on the container.For commercially procured reagents, the manufacturer-assigned expiration date is often used.The current compendia (European Pharmacopeia [Ph Eur], Japanese Pharmacopeia [JP], and United States Pharmacopeia [USP]) typically define the process for re-standardizing the most commonly used volumetric solutions.The preparation of all solutions prepared in the laboratory must be documented.If no expiration date is available, and the material is stable, a company may have a procedure in place that would allow it to assign a predefined expiration period based on the date of receipt.Shorter expiration dates may be required if stability is an issue for the material.
The reserve sample consists of at least twice the quantity necessary to conduct all required testing.Secondary or in-house standards are raw materials that have been assayed against a primary standard.When standards are received into a laboratory, traceability must be established.For example, if a sample is light sensitive, amber glassware is used in the sample preparations.During method validation, solution stability is determined.
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Most laboratories will assign a unique standard number and complete corresponding paperwork indicating the standard’s name, lot number, purity, expiration date, and drying requirements.