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Showing posts with label Pharmacopoeia. Show all posts
Showing posts with label Pharmacopoeia. Show all posts
Friday, December 5, 2008
European Pharmacopoeia, 4th edition
The European Pharmacopoeia is a single reference work for the quality control of medicines in Europe. Several legal texts make the European Pharmacopoeia mandatory:A Convention on the Elaboration of a European Pharmacopoeia ratified in 2003 by 31 European countries and the European Union; European Union directives 2001/83/EC and 2001/82/EC,on medicines for human use and for veterinary use, respectively, maintain the mandatory character of European Pharmacopoeia specifications on medicines as regards their qualitative and quantitative composition and the tests to be carried out on these medicines, the raw materials used in production and the intermediates of synthesis. All producers of medicines or substances for pharmaceutical use therefore must apply the quality standards of the European Pharmacopoeia for the marketing and use of these products in Europe. The texts of the European Pharmacopoeia are legally binding and compliance is enforced by the administrative or juridical authorities. The national authorities of the member states are bound to apply them if necessary replacing any national monograph on the same subject.
The 4th Edition consists of an initial volume 2002 (4.0) and a collection of 8 non-cumulative supplements (4.1) published three times a year following the decisions of each session of the European Pharmacopoeia Commission. With supplement 4.6, the 4th Edition comprises 1750 specific monographs, 285 general methods illustrated by figures or chromatograms and 2140 reagents. Every 4 months a new volume enters into force.
The 4th Edition consists of an initial volume 2002 (4.0) and a collection of 8 non-cumulative supplements (4.1) published three times a year following the decisions of each session of the European Pharmacopoeia Commission. With supplement 4.6, the 4th Edition comprises 1750 specific monographs, 285 general methods illustrated by figures or chromatograms and 2140 reagents. Every 4 months a new volume enters into force.
British Pharmacopoeia 2007
The British Pharmacopoeia (BP) 2007 is the authoritative, current collection of standards for UK medicinal substances and the official source of all UK quality standards. It is an essential reference for anyone involved in pharmaceutical Research & Development, manufacturing and testing, and plays a vital role in ensuring that all medicinal substances on the UK market meet standards of safety, quality and efficacy.
The BP is supplied in a variety of formats designed for ease of use and a wide range of applications. The hard copy edition package contains a boxed five volume set with a separate Veterinary volume, a CD-ROM and access to a comprehensible, regularly updated website. Both the CD-ROM and online formats are easy to network for access across your organisation.
There will not be an edition of the BP entitled 'British Pharmacopoeia 2006'. In order to improve the alignment of the published edition with the effective date of its contents, the forthcoming edition is entitled 'British Pharmacopoeia 2007'.
The BP is supplied in a variety of formats designed for ease of use and a wide range of applications. The hard copy edition package contains a boxed five volume set with a separate Veterinary volume, a CD-ROM and access to a comprehensible, regularly updated website. Both the CD-ROM and online formats are easy to network for access across your organisation.
There will not be an edition of the BP entitled 'British Pharmacopoeia 2006'. In order to improve the alignment of the published edition with the effective date of its contents, the forthcoming edition is entitled 'British Pharmacopoeia 2007'.
Key features:
- Extensive Revisions including 30 new BP texts
- New Supplementary Chapters containing general guidance on
- Unlicensed Medicines and Method Validation
- First BP monograph for Traditional Chinese Medicines
- All European Pharmacopoeia 5th edition material up to and including
- Supplement 5.5 integrated into the text of BP 2007
- Value-for-money networking with full technical support from the publishers
- CD-ROM and website deliver the complete text of the British Pharmacopoeia, British Approved Names and European Pharmacopoeia standards directly to your PC
Japanese Pharmacopoeia (Jp Xiv) (Pharmacopoeia of Japan)
Publisher: Society of Japanese Pharmac
Number Of Pages: 1357
Publication Date: 2002-01
Sales Rank: 3114417
ISBN / ASIN: 4840806721
EAN: 9784840806725
Binding: Hardcover
Manufacturer: Society of Japanese Pharmac
Studio: Society of Japanese Pharmac
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Number Of Pages: 1357
Publication Date: 2002-01
Sales Rank: 3114417
ISBN / ASIN: 4840806721
EAN: 9784840806725
Binding: Hardcover
Manufacturer: Society of Japanese Pharmac
Studio: Society of Japanese Pharmac
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USP NF 2007 (United States Pharmacopeia/National Formulary)
The United States Pharmacopeia is a compendium of quality control tests for drugs and excipients to be introduced into a medicinal formulation. It is published every year [1] by the United States Pharmacopoeial Convention. It forms the basis of enforcement actions by the U.S. Food and Drug Administration and the U.S. Drug Enforcement Administration and is the official pharmacopoeia of the U.S.A. and many other nations. Therefore, in case of a dispute, those methods for, amongst others, identification, assay and purity determination of a drug substance or excipient which are stated in the USP will be the legally binding ones.Within the field the compendium is referred to simply as the USP. The initials USP are affixed to materials' names to indicate that they conform to the specifications in the USP and may be used medicinally.
DOWNLOADIndian Pharmacopoeia 1996
ISBN: 8190065831
Place of Publication: New Delhi
Publisher: The Controller of Publications
Edition: 1st ed.
Year of Publication: 2003
Physical Description: 140p.
Book Format: Hardcover
Language: English
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Place of Publication: New Delhi
Publisher: The Controller of Publications
Edition: 1st ed.
Year of Publication: 2003
Physical Description: 140p.
Book Format: Hardcover
Language: English
The latest edition of the Indian Pharmacopoeia was published in 1996. It was updated by additions and amendments introduced through addendum 2000. Under the Drugs and Cosmetics Act, 1940, the Indian Pharmacopoeia is the legally recognised book of standards for the quality of drug substances and their preparations included therein. In view of the rapid developments is pharmaceutical sciences and technology, it became necessary to make further changes in the existing compendium. Addendum 2002 amends as well as adds new drugs and preparations to the Indian pharmacopoeia 1996 with a view to keeping the pharmacopoeia updated to the extent possible. Besides amending the existing monographs and appendices, it contains 19 new monographs including monographs of 12 antiretroviral drugs and 7 formulations of these substances. A new appendix on residual solvents has been incorporated. Some monographs have undergone major amendments. The appendix on high performance liquid chromatography has been replaced with a new version which also includes the ion chromatography. The Addendum 2002 is a companion volume to the Indian pharmacopoeia which is indispensable for all concerned with the quality of drugs.
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