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Impurities in Pharmaceutical Analysis: Types, Sources, USP & ICH Guidelines, and Advanced Profiling Explained

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What is Impurity? Impurities defined as a foreign particle that affects the purity of a substance. Impurities are chemical substances inside a confined amount of liquid, gas, or solid, which differ from the chemical composition of the material or compound. Impurities in pharmaceuticals are the unwanted chemicals that remain with the active pharmaceutical ingredients (APIs), or develop during formulation. The presence of these […]

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Primary and Secondary Standards in Pharmaceutical Analysis

When we talk about standards, we usually mean a pure substance that is used to prepare solutions of exactly known strength. In simple words, a standard is a “reference chemical” in laboratory work. Standards are mainly of two types: Now, let us understand both in detail. What is a Primary Standard? A primary standard is a highly pure