What is the USP standard?

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 USP purity?

USP grade meets the purity levels set by the United States Pharmacopeia (USP). USP grade is equivalent to the ACS grade for many drugs. NF grade is a purity grade set by the National Formulary (NF). NF grade is equivalent to the ACS grade for many drugs.

What is a USP certificate?

USP Certificates are issued to provide customers with information such as a hard copy of the label text, molecular information, typical chromatograms (limited cases), and additional use/handling information that may not be contained on the RS label.

Which body of USP addresses specific standards?

Expert Committees address specific standards-setting areas within USP such as Chemical Medicines, Biologics and Biotechnology, General Chapters, and others. Expert Committee members are elected by the Council of Experts.

Is USP recognized by FDA?

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. These standards are enforced by the U.S. Food and Drug Administration (FDA), states and other oversight organizations.

What does USP 797 guidelines include?

USP 797 outlines areas that require policies and procedures to ensure drug and patient safety. These areas include: Verification of compounding accuracy and sterility. Environmental quality and control.

What are NF standards?

The USP–NF is a combination of two compendia, the United States Pharmacopeia (USP) and the National Formulary (NF). It contains standards for medicines, dosage forms, drug substances, excipients, biologics, compounded preparations, medical devices, dietary supplements, and other therapeutics.

What does FCC grade mean?

CP (Chemically Pure) Grade—Products of purity suitable for use in general applications. FCC Grade—Products that meet the requirements of the current Food Chemical Codex. GenAR—A line of reagents specifically developed for use in biotechnology and genetic research.

Is ACS grade better than USP?

Reagent grade is generally equal to ACS grade (≥95%) and is acceptable for food, drug, or medicinal use and is suitable for use in many laboratory and analytical applications. USP grade meets or exceeds requirements of the United States Pharmacopeia (USP). This grade is acceptable for food, drug, or medicinal use.

Does USP require GMP?

USP offers the option for a stand-alone GMP audit; it is not just compulsory to join the USP Verification Program in order to participate in USP’s Quality Systems GMP Audited Verification Program. The program requires an annual GMP audit of the facility.

What is difference between USP and USP-NF?

USP–NF is a combination of two compendia, the United States Pharmacopeia (USP) and the National Formulary (NF). Monographs for drug substances, dosage forms, and compounded preparations are featured in the USP. Monographs for dietary supplements and ingredients appear in a separate section of the USP.

What does USP 23 mean?

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 is the difference between USP 797 and 800?

USP 797 provides standards for compounding of sterile preparations while USP 800 provides standards for the safe handling of HDs to minimize exposure risks. USP 797 promotes the protection of the sterility of the drug, while USP 800 is focused on the safety of personnel who come in contact with the HDs.

Who does USP 797 apply to?

USP 797 applies to everyone involved in sterile compounding: pharmacists, nurses, physicians and pharmacy technicians. Staff USP 797 training should cover best practices and core competencies for each type of employee, ideally in a hands-on, situation-based learning format with both practical and written exams.

Is USP 797 mandatory?

The US Pharmacopeia (USP) chapters on Sterile Compounding (USP 797) and Safe Handling of Hazardous Drugs (USP 800) are only legally enforceable when an entity with authority over the medical practice or hospital (eg, a state Board of Pharmacy, state Board of Medicine, or Occupational Safety department) chooses to make …

What is 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 3 USP mean?

Look in your medicine cabinet, chances are you have a popular first aid antiseptic with a label that reads “Hydrogen Peroxide Topical Solution 3% USP” or something similar. Those 3 letters on the label means this product was made to USP standards.

What is IP and USP in medicine?

Drugs manufactured in India have to be labelled with the mandatory non-proprietary drug name with the suffix I.P. This is similar to the B.P. suffix for British Pharmacopoeia and the U.S.P. suffix for the United States Pharmacopeia.

What is the difference between USP 795 and USP 797?

Chapter 795 focuses on applying good compounding practices to the process of preparing nonsterile compounded formulations, while Chapter 797 provides procedures and requirements for compounding sterile preparations.

What are the 3 risk levels USP 797?

As of today, USP 797 (2008) is the currently official chapter and low, medium, or high-risk levels apply.

What does USP 795 mean?

USP 795 indicates that “areas used for sterile preparations shall be separated and distinct from the nonsterile compounding area.” Now, areas for sterile preparations are covered under USP 797 and USP 800, and require a completely separate ISO suite, so that automatically sets up a separate sterile compounding area.

What is difference between BP and EP?

EP — European Pharmacopoeia is a major regional pharmacopoeia which provides common quality standards throughout the pharmaceutical industry in Europe to control the quality of medicines, and the substances used to manufacture them. BP —The British Pharmacopoeia (BP) is the national pharmacopoeia of the United Kingdom.

Is USP NF a drug reference?

USP Reference Standards are highly characterized specimens of drug substances, excipients, food ingredients, impurities, degradation products, dietary supplements, compendial reagents and performance calibrators used in conducting tests and assays for USP–NF and FCC.

What does NF mean in chemicals?

In the case of the chemical industry, there are two primary standards commonly known as USP Grade and NF Grade. The two organizations, National Formulary (NF) and the United States Pharmacopeia (USP) provide the standards for drugs, dosages, chemicals, preparations, and so on.

What is difference between LR and AR grade?

AR is used for sophisticated instruments and for research activities which accuracy is so important. However, for teaching purpose you may use LR chemicals or sometimes industrial reagent (IR). LR grade can be used for general purposes and again sometimes, these can be used teaching purpose.

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