Drug reference standard

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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.

Drug reference Standards are highly characterized specimens of drug substances, excipients, reportable impurities, degradation products, compendial reagents, and performance calibrators. They are explicitly required in many Pharmacopeial assays and tests and are provided solely for such use. Assessment of the suitability for use in other application(s) rests with the purchaser.

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