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Testing of identity, strength, quality and purity of pharmaceuticals such as drug substances, excipients and products requires them to be compared with a substance which is highly purified and characterized. The US Pharmacopeia (USP) defines reference standard materials as "highly…
The whole pharma world goes berserk in meeting the ‘product specifications’ as required by various regulatory authorities. Pharmacopeial specifications, In-house specifications, product specific specifications are various types of specifications that are required to be met by a product before release…