Is chemical purity/assay for Antibiotics enough? These days more - TopicsExpress

Is chemical purity/assay for Antibiotics enough? These days more than few labs (Pharma in particular) are performing only chemical analysis for purity of antibiotics without performing its bio-assay. Is this practice is enough? Only chemical assay is enough or both bio-assay and chemical assay should be performed? what is the Quality and regularity stance on this matter? How would one justify if an antibiotic is chemically pure but micro-biologically impotent, as it is unable to perform its core function that is to act as bactericidal or bacteriostatic?

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