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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…
Going by the classical definition, an impurity can be defined as an unwanted chemical substance which differs from the chemical composition of the material in question. In pharmaceutical preparations, impurities identification, assessment and quantification play a vital role in evaluating…
April 21, 2021 Indian Pharmacopoeia Commission (IPC), Ministry of Health and Family Welfare, Government of India has introduced a new draft General Chapter on ‘Approach to Alternative Rapid Microbiological Method’. The proposed methods would enable faster laboratory testing of the…
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…