What are Compendial reference standards?
Unlike a typical primary and secondary standard, primary and secondary compendial standards undergo rigorous testing in a collaborative study and are subject to statistical analysis. Compendial standards are considered to have the highest level of accuracy and traceability.
Is NF and USP the same?
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 difference between BP and EP?
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.
What is the difference between USP and BP?
The USP is an independent scientific organisation that develops quality standards for medicines, dietary supplements and food ingredients. The BP is a book of published and publicly available standards for pharmaceutical ingredients and finished medicinal products.
What does USP 23 mean?
PHARMACEUTICAL INDUSTRY REQUIREMENTS. PHARMACEUTICAL INDUSTRY REQUIREMENTS. USP XXIII. The United States Pharmacopeia XXIII was put partially into effect in January 1995 and has requirements somewhat different than its predecessor which specified that water for injection be produced by distillation or reverse osmosis.
What does Compendial mean?
Adjective. compendial (not comparable) Related to a compendium that serves as a standard, such as the British Pharmacopoeia, or the US Pharmacopeia.
What is NF grade?
NF grade is a purity grade set by the National Formulary (NF). NF grade is equivalent to the ACS grade for many drugs. Laboratory grade is suitable for use in educational settings, but is not acceptable for food or drug use.
What is pharmaceutical monograph?
A Product Monograph is a factual, scientific document on a drug product that, devoid of promotional material, describes the properties, claims, indications and conditions of use of the drug and contains any other information that may be required for optimal, safe and effective use of the drug.
Is EP same as Ph Eur?
Answer: The official abbreviation is ‘Ph. Eur. ‘ and not ‘EP’ (which is registered for the European Parliament).
What is current version of USP?
The current version of USP–NF standards deemed official by USP are enforceable by the U.S. Food and Drug Administration for medicines manufactured and marketed in the United States. The current version, USP–NF 2021, Issue 1, will become official on May 1, 2021.
Is USP the same as pharmaceutical grade?
In short, USP is the same as pharmaceutical grade. If you are looking for pharmaceutical grade chemicals and solvents in bulk for the production of hand sanitizer, or other personal care products Ecolink can help. Ecolink is a trusted, environmentally-friendly bulk supplier of high purity chemicals.
What is USP testing specifications?
Developing documentary standards and Reference Standards is the core of what we do at USP. These standards help to assess the quality, strength, identity, and purity of chemical medicines, biologics, food chemicals and ingredients, dietary supplements, among other items.