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…


As per regulatory requirements, each API, inactive ingredient, finished good, packing material and other related material shall be tested as per the specifications before use and prior to their release in the market for commercial use. But is it required…
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