Drug reference standard
A reference standard is a standardized object or substance which is used as a measurement base for similar objects or substances.
Examples of primary reference standards
The reference standard for a kilogram is the one kilogram mass of a platinum-iridium kilogram maintained by the Bureau International des Poids et Mesures in Sevres, France.
The reference standard for length is the meter - the distance light travels in a vacuum during 1/299,792,458 of a second.
Secondary reference standards
Secondary reference standards are very close approximations of primary reference standards. For example, national measuring laboratories may house stainless steel balls of one kilogram which are used to set standards for manufacturing supermarket measuring scales.
Chemical and drug reference standards
The United States Pharmacopeia (USP) states:
- "The United States Pharmacopeia (USP) is an official public standards–setting authority for all prescription and over–the–counter medicines and other health care products manufactured or sold in the United States. USP also sets widely recognized standards for food ingredients and dietary supplements. USP sets standards for the quality, purity, strength, and consistency of these products–critical to the public health. USP's standards are recognized and used in more than 130 countries around the globe. These standards have helped to ensure public health throughout the world for close to 200 years."
USP also states:
- "USP's official Reference Standards are highly characterized specimens of drug substances, excipients, impurities, degradation products, dietary supplements, compendial reagents and performance calibrators. They are required for use in conducting official USP–NF tests and assays."