In this post, you can download United State Pharmacopeia 2007 (USP 30 - NF 25) in software for free. There are 6 Volumes available of United State Pharmacopeia 2007 (USP 30 - NF 25).
USP 30–NF 25
This section provides background information on the United States Pharmacopeial Convention
(USP), as well as general information about the 30th revision of the United States Pharmacopeia (USP 30) and the 25th edition of the National Formulary (NF 25). Additional official information about the specific uses of these texts is provided in the General Notices and Requirements (page 1).
MISSION STATEMENT
USP–NF is published in continuing pursuit of the mission of USP: The United States Pharmacopeia promotes the public health and benefits practitioners and patients by disseminating authoritative standards and information developed by its volunteers for medicines, other health care technologies, and related practices used to maintain and improve health and promote optimal health care delivery.
Working with many constituencies and stakeholders around the world, USP's compendial activities support the availability of safe, effective, good-quality pharmaceutical care for all.
HISTORY
On January 1, 1820, 11 physicians met in the Senate Chamber of the U.S. Capitol building to establish a pharmacopeia for the United States. These practitioners sought to create a compendium of the best therapeutic products, give them useful names, and provide recipes for their preparation. Nearly a year later, on December 15, 1820, the first edition of The Pharmacopoeia of the United States was published. The preface to the 1820 edition read, It is the object of a Pharmacopoeia to select from among substances which possess medicinal power, those, the utility of which is most fully established and best understood; and to form from them preparations and compositions, in which their powers may be exerted to the greatest advantage. It should likewise distinguish those articles by convenient and definite names, such as may prevent trouble or uncertainty in the intercourse of physicians and apothecaries. This mission continues today within USP. Over time, the nature of the US Pharmacopeia (USP) has changed from a set of prescriptions to a set of pharmaceutical product standards. Its release timetable has also been changed. From 1820 to 1942, the USP was issued with a gap of 10 years. from 1942 to 2000, every 5 years; It annually starts from 2002.
In 1888, the American Pharmaceutical Association published the first national formula, the National Unofficial Formula (NF). Both USP and NF were recognized in the Federal Food and Drug Administration Act of 1906 and then the Federal Food, Drug and Cosmetic Act of 1938. In 1975 he acquired the National Formulary (NF) USP and began publishing two abstracts in one volume entitled USP-NF.
Today, the USP continues to develop the USP-NF through the work of the Summary Expert Council, which provides standards for articles based on advances in analytical science and metrology. As these and related sciences advance, so do the USP and NF.
USP 30 – NF 25
The content of USP 30 – NF 25 is effective from 1 May 2007 unless otherwise stated. USP-NF contains official monographs for materials and products. The terms official substance and official preparation are defined in the General Notices of this Pharmacopeia. USP 30–NF 25 contains science-based standards for drugs, biologics, dietary supplements, and excipients used in dosage forms and products. With few exceptions, all articles for which monographs are provided in USP 30–NF 25 are legally marketed in the United States or are contained in legally marketed articles.
A USP–NF monograph for an official substance or preparation includes the article's definition; packaging, storage, and other requirements; and a specification. The specification consists of a series of universal (description, identification, impurities, assay) and specific tests, one or more analytical procedures for each test, and acceptance criteria. Ingredients are defined as either drug substances or excipients. An excipient is any component, other than the active substance(s), intentionally added to the formulation of a dosage form. Excipients are not necessarily inert. Drug substances and excipients may be synthetic, semi-synthetic, drawn from nature (natural source), or manufactured using recombinant technology. Larger molecules and mixtures requiring a potency test are usually referred to as biologicals or biotechnological articles
USP 30–NF 25 contains approximately 4,100 monographs and more than 200 General Tests and Assays (General Chapters numbered 1,000 and below) and General Information Chapters
(numbered above 1,000). General Chapters provide frequently cited procedures, sometimes with acceptance criteria, in order to compile into one location repetitive information that appears in many monographs. New and revised monographs and General Chapters and obsolete matter deleted from this edition are indicated on page xxxviii in the Admissions section.
Organization of USP 30–NF 25— USP 30–NF 25 is printed as a three-volume set, due to the increase in content. Volume 1 includes Front Matter (Mission and Preface, People, Collaborators, Members, Preambles [formerly called Appendices], Admissions/Annotations, and Commentary). It also includes USP General Notices, General Chapters, Dietary Supplement Chapters, Reagents, Reference Tables, Dietary Supplement Monographs, NF General Notices, Excipients, and NF Monographs. Volume 2 includes USP monographs A–L and Volume 3 includes USP monographs M–Z. Volumes 2 and 3 also include the USP General Notices and the Guide to General Chapters, and all three volumes include the full index. Monographs for drug substances and preparations—with the exception of dietary supplements—appear in the first section of USP.
OTHER USP–NF RELATED PUBLICATIONS
Chromatographic Reagents— This comprehensive reference provides detailed information needed to conduct chromatographic procedures found in USP–NF. Chromatographic Reagents lists the brand names of the column reagents cited in every proposal for new or revised gas- or liquid-chromatographic analytical procedures that have been published in PF since 1980. Chromatographic reagents help keep track of columnar reagents used to validate formal analytical methods. Brand column list is updated every 2 months with PF.
USP Pharmacopeia - The USP-NF is primarily intended for manufacturers of pharmaceuticals and dietary supplements, but includes many monographs and related texts to assist them. To better address the needs of these physicians and the pharmaceutical community in general, USP has made USP Pharmacopoeia Pharmacopoeia available. This text provides simplified official pharmacy related texts of USP-NF and verified information. The former represents the standard for official articles, the latter is general information useful to experts. Both types of text were developed according to the rules and procedures of the Expert Committee. The USP Pharmacopoeia of Pharmacists is available in print and on the web.
USP-NF Review Process
Public Engagement: Although the USP Board of Experts is the final decision-making body for USP-NF standards, these standards have been developed through an excellent public engagement process and hands-on interaction between the USP and its stakeholders, both nationally and internationally. Participation in the review process is the result of the support of many individuals and groups, as well as scientific, technological and commercial organizations.
Requests for revision for monographs, either new monographs or those needing updating, contain information submitted voluntarily by manufacturers and other interested parties. At times USP staff may develop information to support a monograph Request for Revision. USP has prepared a document titled Guideline for Submitting Requests for Revision to USP–NF (available at
www.usp.org, click on USP–NF). Via PF, USP solicits and encourages public comment on these monographs, General Chapters, and other draft documents. USP scientific liaisons to Expert Committees review these responses and create draft proposals that are provided to the Council of Experts. The project is formalized when a committee of experts votes for it to be formalized in the USP-NF. The USP standards setting process therefore provides an opportunity for those who manufacture, regulate, and use therapeutic products to comment on the development and revision of the USP-NF standard. Because of the voting process and its special legal relationship with the US government, the USP is not considered a voluntary normative consent body. Figure 2 shows the relationship between the public review and solicitation process and standards development.