Dear Members,
I looking for information about API comparison - the same substance but different supplier .What kind of factors you evaluates ?
Best regards
Specifications, assay, related substances, method of manufacture, form (powder versus crystals)…
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Regarding the rekevant issues about API comparison, is important bearing in mind the pharmaceutical form of the finished product. In this sense, polymorphic forms or particle size ard important factors for powders, oral and semisolids medicinal producs. Related substances (including residual solvents and inorganic impurities) are also relevant for API. Of course, potency and specifications.
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