The Bioanalysis Glossary • 353 reference standard Sponsored by


A well-characterized substance used to spike calibration standards and quality control samples (QCs) samples in a method, accompanied by a certificate of analysis (CoA) that provides the purity and expiration (or retest) date.


Reference standards are substances used for analytical testing during


pharmaceutical manufacturing. Specified and accredited by regulatory authorities or in-house procedures, reference standards are used to verify the target substance and confirm its safety, integrity, strength, purity, and overall makeup. While the public is normally unaware of their existence, standards have an incredible effect on the overall health system, as they specify the accepted quality of a drug by analytical means. Reference standards are used not only for active drug ingredients but also for reagents and other substances common in pharmaceutical research. The various stages in drug research and manufacturing require certain specifications to be met in order to comply with regulatory guidelines. Standards improve safety by allowing scientists to prove that a drug material will not harm its intended user. They help manufacturers confirm molecular integrity and show that a drug is manufactured according to the appropriate specifications. They can be used to measure the strength or potency of declared active ingredients. They are also a marker of purity, which is essential to check for harmful side products. Compendial primary standards are produced by an issuing recognized


Pharmacopoeia and are considered of the highest metrological quality. They serve as an accepted value without reference and are designed for use in compendial methods. They are considered to have the highest order of traceability possible. Certified reference materials are metrologically valid for procedures for a


specified property or properties. Their property value, associated uncertainty, and metrological traceability are all provided in an included certificate. They must be manufactured under accreditation (ISO 17034 for manufacturing or 17025 for testing applications), with values assigned by an accredited laboratory. Merck provides more than 1000 certified reference materials at


SigmaAldrich.com. Customers will find compendial primary standards from the United States Pharmacopeia, the European Directorate for the Quality of Medicines, as well as the British Pharmacopeia,. We also provide standard selection guides, methods, notices on Pharmacopeia updates, and personalized support to ensure that analytical scientists feel better about their quality control process and carry these benefits to their entire lab and organization.


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Bioanalysis (2018) 10(21) Suppl. 1


future science group


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