What is chemical reference substance?
A designated primary chemical reference substance is one that is widely acknowledged to have the appropriate qualities within a specified context, and whose assigned content when used as an assay standard is accepted without requiring comparison with another chemical substance.
What are the official references or compendia that can be used in determining the drug’s standard and specification?
Reference standards can be compendial or noncompendial and are typically obtained from the following sources. Compendial (primary): Pharmacopeias such as the United States Pharmacopeia (USP), European Pharmacopoeia (EP), or Japanese Pharmacopoeia (JP)
What are secondary reference standards?
A secondary chemical reference substance is a substance whose characteristics are assigned and/or calibrated by comparison with a primary chemical reference substance. The extent of characterization and testing of a secondary chemical reference substance may be less than for a primary chemical reference substance.
What is reference standard qualification?
Qualified reference standards provide proof of continuous quality of starting material and drug substances, and allow monitoring of other substances including excipients, impurities, and byproducts throughout the entire process.
Is EP and BP same?
The BP contains thousands of monographs and one of our areas of expertise is in finished products, while the EP predominantly focuses on starting materials and active pharmaceutical ingredients. This enables the BP to act as a single reference source for pharmacopoeia compliance in the UK.
What is difference between USP and NF?
USP–NF is a combination of two compendia, the United States Pharmacopeia (USP) and the National Formulary (NF). Excipient monographs are in the NF. However, if an excipient is also used as a pharmaceutical active in an FDA-approved product released in the US, its monograph will appear in the USP section instead.
What is secondary reference material?
Secondary Reference Material Material used for verification of a secondary reference method, traceable to the primary reference standard. This material may also be used for verification of a routine method if shown to be commutable.
What is a drug reference?
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.
What is a CRM in chemistry?
Certified Reference Materials (CRMs) are ‘controls’ or standards used to check the quality and metrological traceability of products, to validate analytical measurement methods, or for the calibration of instruments. Reference materials are particularly important for analytical chemistry and clinical analysis.