USP-NF monograph

USP-NF Supplements are published twice a year. They contain all the approved changes to USP-NF Monographs and General Chapters as well as newly adopted monographs. 

All FDA-approved drugs products must meet the quality requirements described in the U.S. Pharmacopeia (USP) (1,2). If a drug product is to be manufactured elsewhere in the world but marketed in the United States, compliance with existing USP-NF monographs is crucial. Non-compliance may result in the FDA blocking entry of the product into the U.S. market or removing the product from the market. For other markets compliance with USP standards is not binding. For... 

NDA applicants are required to submit a list of all excipients (as well as other drug components), used in the manufacture of a proposed new drug. Additionally, the applicant must provide sufficient information to establish that the use of each excipient is safe for its intended use, at its intended quantity. This information includes safety data, a statement of the composition, specifications, and any analytical methods used for the excipient. When a USP/NF monograph exists for an excipient, the applicant may state that the excipient in the drug will comply with the standards in the monograph instead of providing composition, specification, and analytical method information. The required safety information includes... 

The existing structure for review of excipient ingredients has several structural defects that result in significant disincentives in the development of novel excipients. Currently, only excipients that have been approved in an NDA are subject to a USP/NF monograph, or excipients that have an FDA- or a JECFA-sanctioned food... 

Aspartame is GRAS listed, and is accepted as a food additive in Europe and is in the FDA Inactive Ingredients Guide. It is included in non-parenteral medicines licensed in the UK, and is listed in the USP-NF, BP, JP, and EP. Aspartame is the subject of a monograph in the Food Chemicals Codex issued by the National Academy of Sciences. This document is very similar to the corresponding USP-NF monograph. 

The proposed United States Pharmacopoeia National Formulary (USP-NF) monograph for hypericum requires that products contain a minimum of 0.04% of hypericins (95). 

USP-NF monographs include assays and various analytical methods—identification, dissolution, content uniformity, etc. USP-NF also provides guidance and standards on biotechnology, radiopharmaceuticals, pharmacy compounding, and pharmaceutical waters. General chapters outline requirements for microbiological, biological, chemical, and physical tests and assays. 

The United States Pharmacopeia/National Formulary contains a section or monograph on each of the following gases air, carbon dioxide, cyclopropane, helium, nitrogen, nitrous oxide, and oxygen. Definite standards and methods of testing are prescribed in each USP/NF monograph to assure a product of appropriate quality and purity. 

The GeneralNlotices. These are the basic requirements for the appheation and interpretation of the tests and specifications that foUow in the USP-NF. Many of the terms used in the text are defined, and the majority of procedural questions that may arise within the monograph for each substance are answered. 

The Standard-Setting Process. Settiag USP-NF standards is a continuing, and by no means unilateral, process. The Committee of Revision not only develops monographs for new substances but also continually reviews the monographs, specifications, and testing methods for existing substances. Results are pubHshed in one or more supplements each year. A complete review is done every five years and a revision is pubHshed. 

The FCC is to food-additive chemicals what the USP—NF is to dmgs. In fact, many chemicals that are used in dmgs also are food additives (qv) and thus may have monographs in both the USP—NF and in the FCC. Examples of food-additive chemicals are ascorbic acid [50-81-7] (see Vitamins), butylated hydroxytoluene [128-37-0] (BHT) (see Antioxidants), calcium chloride [10043-52-4] (see Calcium compounds), ethyl vanillin [121-32-4] (see Vanillin), ferrous fumarate [7705-12-6] and ferrous sulfate [7720-78-7] (see Iron compounds), niacin [59-67-6] sodium chloride [7647-14-5] sodium hydroxide [1310-73-2] (see lkaliand cm ORiNE products), sodium phosphate dibasic [7558-79-4] (see Phosphoric acids and phosphates), spearmint oil [8008-79-5] (see Oils, essential), tartaric acid [133-37-9] (see Hydroxy dicarboxylic acids), tragacanth [9000-65-1] (see Gums), and vitamin A [11103-57-4]. 

The first official injection (morphine) appeared in the British Pharmacopoeia (BP) of 1867. It was not until 1898 when cocaine was added to the BP that sterilization was attempted. In this country, the first official injections may be found in the National Formulary (NF), published in 1926. Monographs were included for seven sterile glass-sealed ampoules. The NF and the United States Pharmacopeia (USP) published chapters on sterilization as early as 1916, but no monographs for ampoules appeared in USP until 1942. The current USP contains monographs for over 500 injectable products [1]. 

Users of the pharmacopeias are appropriately informed of the harmonization status of monographs and general chapters. In the European Pharmacopoeia (EP) and USP-NF, for general chapters, this is done via a preliminary paragraph. For the JP, a notification is made by the MHLW and information is given in a general chapter. 

Excipient and vendor selections can greatly influence the new drag development timeline, product performance, and acceptance of final products. Compendial excipients have composition consistent with monographs published in compendia such as USP-NF these are the better-characterized excipients. These excipients most likely possess desirable qualities and are preferred excipients for pharmaceutical formulations. Non-compendial excipients can also be used for drug products if they are supported by Type IV dmg master files (DMFs) in regulatory dossiers. Overall, a good excipient supplier should 29... 

There are at least 14 USP, NF, or BP bulk drug monographs that use flame photometry either to control sodium potassium as an impurity or to assay for the primary ion (Table An external standard... 

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