Reagent

Reagents are an integral part of any laboratory and as such play a vital role in ensuring the validity of analytical results.  Reagents must be suitable for the intended use.    Consideration should be given to the accompanying documentation and appropriate physico-chemical or biological critical quality attributes for the intended purpose/s.   In the laboratory,…

How does FDA interpret the regulations (21CFR part 211) regarding the establishment of expiry dating for chemicals, reagents, solutions, and solvents?   Laboratory “reagents, and standard solutions,” as referenced in the CGMP regulations at 21 CFR 211.194, includes laboratory chemicals such as solvents (including mobile phases), dry chemicals (salts, primary standards, etc.), and solutions (#buffers,…