What is USP?
As discussed on the Puritan blog, the United States Pharmacopeial Convention, Incorporated, (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. The organization was founded in 1820. In 1975 it merged with the National Formulary and Drug Standards Laboratory (NF). The combined organizations publish the USP-NF which is a book of public pharmacopeial standards. It is published yearly. Monographs for drug substances, dosage forms, and compounded preparations are featured in the USP. Monographs for dietary supplements and ingredients are in a separate section of the USP. Monographs for excipients are in the NF. In 2006 the USP acquired the Food Chemicals Codex (FCC). The FCC is a compendium of internationally recognized standards for the purity and identity of food ingredients.
What is USP Grade?
USP Grade means that a product meets all of the requirements as contained in the USP monograph for that product and is manufactured in a cGMP compliant facility. If there is no USP monograph, a material cannot be labeled as USP Grade.
What is NF Grade?
NF Grade means that a product meets all of the requirements as contained in the NF monograph for that product and is produced in a cGMP compliant facility. If there is no NF monograph, a material cannot be labeled as NF Grade.
Can a product be both USP Grade and NF Grade?
Glacial Acetic Acid has both a NF monograph and a USP monograph. If a sample is tested and meets the requirements listed in both monographs, it could be labeled as both USP and NF Grade. However, it is much more likely that a product monograph will exist in either the USP or the NF.
What is a monograph?
A monograph includes the name of the ingredient or preparation; the definition; packaging, storage, and labeling requirements; and the specification. The specification consists of a series of tests, procedures for the tests, and acceptance criteria.
Tests and procedures referred to in multiple monographs are described in the USP-NF general chapters.
What is an excipient?
An excipient is a type of raw material that is present in a drug product and thus has direct patient contact. It is not an active pharmaceutical ingredient (API). Excipients include inert materials such as bulking agents, stabilizing agents, preservatives, salts, or solvents. An excipient must be evaluated for safety unless it has been approved as a “generally recognized as safe” (GRAS) material or is on a list of approved excipients.