What does USP standard mean?

A USP Reference Standard (also known as a physical standard) is a known quantity of a drug substance or ingredient, developed in alignment with the specifications outlined in the USP–NF.

What is the USP and what do they regulate?

USP is a scientific nonprofit organization that sets public standards for identity, strength, quality and purity of medicines. USP standards are recognized in various provisions of the federal Food, Drug and Cosmetic Act (FDCA) and in laws, regulations and policies promulgated by states.

What is the current USP monograph?

The current version, USP–NF 2021, Issue 1, will become official on May 1, 2022. An ISO certified Spanish translation (certified to ISO 17100:2015 ) of USP–NF compendial content is available as the Spanish USP–NF Online.

How many USP standards are there?

3,500 Reference Standards
USP currently offers more than 3,500 Reference Standards—highly characterized specimens of drug substances, excipients, food ingredients, impurities, degradation products, dietary supplements, compendial reagents and performance calibrators.

What is your USP answer?

A unique selling point defines your company’s unique position in the marketplace, getting at the heart of your business: the value you offer and the problem you solve. A strong USP clearly articulates a specific benefit – one that other competitors don’t offer – that makes you stand out.

What is USP in manufacturing?

One of the most important ways manufacturers can gain a competitive advantage is to produce, position and promote their products within clear Unique Selling Propositions (USP). They are the core values of your products, and they inform and support the whole manufacturing process – from R&D to delivery.

How many editions of USP are there?

About the USP-NF The first printing of the U.S. Pharmacopeia was in 1820. Since then, 43 editions have been published.

When was the last time the USP Daily Reference standards were updated?

Last Updated On: July 7, 2015 USP Daily Reference Standards Catalog Page 11 Catalog # Description Current Lot Previous Lot CAS # NDC # Unit Price Special Restriction

What is a USP standard?

USP standards for drug reference standards are used to demonstrate identity, strength, purity and quality for medicines, dietary supplements and food ingredients.

What are the USP standards for drug references?

What is the difference between primary and secondary USP standards?

USP’s Reference Standards are considered primary standards, except for certain biological USP Reference Standards with units of activity that are established against and traceable to the World Health Organization International Standards. USP does not develop secondary reference standards against its own primary reference standards.