A drug reference standard is a standardized substance which is used as a measurement base for similar substances. Where the exact active substances of a new drug are not known, a reference standard provides a calibrated level of biological effects against which new preparations of the drug can be compared. drug reference solutions and patient education materials put the best available information into the hands of clinicians and patients. They supply critical information regarding dosage, efficacy, interactivity and allergies, even suggesting alternate therapies as appropriate. Drug Reference Standards are highly characterized physical specimens used in testing by pharmaceutical and related industries to help ensure the identity, strength, quality, and purity of medicines (drugs, biologics, and excipients), dietary supplements, and food ingredients. All chromatographic reference standards are supplied with a certificate of analysis certifying the identification and purity of the compound.
A particular lot or batch of drug substance specifically prepared, either by independent synthesis or by additional purification of production material, and shown, by an extensive set of analytical tests, to be authentic material of the highest purity reasonably attainable. It is usually used for structural elucidation, and is the benchmark for working standards.
A reference standard, or reference material, is a substance prepared for use as the standard in an assay, identification or purity test. It has a quality appropriate to its use. For new drug substances reference standards intended for use in assays, the Impurities should be adequately identified and/or controlled and purity should be measured by a quantitative procedure.
