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See Latest ArticlesReference-Standard Material Qualification
Pharmaceutical Technology, 08/24/09
Browne DC et al. – The US Food and Drug Administration defines a reference–standard material as a "highly purified compound that is well characterized". The US Pharmacopeia defines reference–standard materials as "highly characterized specimens of drug substances, excipients, reportable impurities, degradation products, compendial reagents, and performance calibrators". Scientists performing analytical testing use reference standards to determine quantitative as well as qualitative data, performance standards, and calibrators. The quality and purity of reference standards, therefore, are critical for reaching scientifically valid results.
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