Reference Standards, Types, Uses, Preparation & Qualification:

 

A reference standard material is defined as highly purified compound that is well characterized by FDA (US Food and Drug Administration) or company or laboratory. Reference standards are highly characterized specimens of drug substances, excipients, reportable impurities, degradation products, compendial reagents, and performance calibrators by USP (US Pharmacopeia). Reference standards are used to determine quantitative data (such as assay and impurity), qualitative data (such as identification test), and calibration (such as melting point standard). Therefore, the quality and purity of the reference standards are crucial to achieve scientifically valid results

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