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K. Swetha*, K.Shilpa, A. Ajitha, Dr.V. Uma Maheswar Rao.


Reference substances are specifically required in many pharmacopoeial tests and assays. They are selected for their high purity, critical characteristics and suitability of the analytical method. Standards and reference substances play a vital role in evaluating the quality of active pharmaceutical ingredients and finished products. They are highly characterized specimens of drug substances. Reference substances are maintained and distributed by the central drug laboratory in Calcutta. The purpose of having reference standards is to achieve accuracy and reproducibility of the analytical results required by pharmacopoeial testing and pharmaceutical control in general. Each standard is generally established for a specific analytical purpose, defined by the issuing body. Reference Standards of different Pharmacopoeia are in practice (say USP,IP,BP), play a role in Limit tests for impurities or related compounds, Assays for drug substances and for formulations, Qualitative uses, such as identification tests, system suitability tests, chromatographic peak markers, Chromatographic and spectrophotometric procedures.

Keywords: Pharmacopoeia, Chromatography, Accuracy, Reproducibility.

[Full Text Article]

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