These days more than few labs are performing only chemical analysis for purity of antibiotics without performing it's 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 it's core function that is to act as bactericidal or bacteriostatic?
I assume that you are testing purity for quality control purposes? If so, then yes, bioactivity testing is necessary as compounds may lose potency over time. If you are talking about drug discovery, it would be even more necessary. However, remember that with bioactive phytochemicals, purity may not necessarily be a good thing as many compounds interact synergistically for greater effect. I have attached a recent study that shows that the activity of current antibiotics may be increased with the addition of other compounds (in this case, extracts)
Article Interactive antimicrobial and toxicity profiles of conventio...
No, of course not.
Purity is the first condition, but many requirements, such as: crystallisation, polymorphysm, solvatomorphysm, stereoisomerism...
and of course a lot of othe biologic activity requirements, you mai consult in European Standards
WHO International Standards for Antibiotics (ISA)
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