Expiry dating for reagents and solutions in laboratories
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If the manufacturer suggests an expiry date, that date should be followed. 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. For in-house prepared solutions like as mobile phases or other non-quantitative solutions , the FDA expects an assessment to be carried out, too. However, the FDA requires formal stability studies to be performed to determine an appropriate expiry for in-house prepared solutions used for quantitative analysis in assay or impurity testing.
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Laboratory reagents and solutions are used in analytical tests of components, in-process materials, and finished products. For in-house prepared solutions, such as mobile phases or other non-quantitative solutions, FDA would expect that an assessment be conducted again, literature review may be acceptable to determine an appropriate expiry period. However, for in-house prepared solutions used for quantitative analysis, such as sample or standard solutions used in assay or impurity testing or titration solutions, FDA requires that formal stability studies be conducted to determine an appropriate expiry. As mentioned in Guidance for Industry: Q2B Validation of Analytical Procedures: Methodology, the stability of analytical solutions is a typical method variation that should be evaluated during robustness testing during method validation. Method validation is a CGMP requirement.
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Could you tell me a reference to the guideline which describes the self life of volumetric solution? I am looking for a formal guideline. Ok, but there I could not find volumetric solutions method. Where can I read RSD less than 1.