Kurztext
The United States Pharmacopeia (USP) and the National Formulary (NF) are the official compendia of standards for drugs, excipients, dietary supplements, biologics and other therapeutic products for the United States and several other countries.
The USP – NF serves as a clear, step-by-step guide for chemical, physical, biological, and microbiological tests, procedures, and acceptance criteria for manufacturing and quality control. USP 36 – NF 31 is official May 1, 2013 to April 30, 2014.
- Established standards serve as a reputable reference point for developing new products and setting SOPs.
- Official monographs and methods help you establish and validate analytical methods, prepare for inspection,maintain compliance, and train new staff on proper techniques.
- Harmonized standards can help you cost-effectively create products for international markets.
In the print version, each new edition or supplement includes changes made since the previous edition. The electronic formats provide also cumulative content and a variety of search, cut and paste, and book-marking capabilities and include viewable 3-D chemical structures. The USP–NF is used by QA/QC professionals, R&D scientists, compendial affairs and regulatory professionals, pharmaceutical manufacturers, compounding pharmacists, lawyers, and pharmacy and medical schools worldwide.
- Standards deemed official by USP are FDA-enforceable for drugs manufactured or marketed in the United States.
- More than 4,600 monographs include specifi cations of identity, strength, quality, purity, packaging, and labeling for substances and dosage forms.
- More than 250 General Chapters provide step-by-step guidance for essential tests and assays, plus helpful industry information.
- Focus-specifi c charts and reference tables make it easy to find the information you need!
- New streamlined monograph format has been incorporated for new and revised content since USP 33–NF 28 Reissue.
Content:
Mission Statement and Preface • People • Admissions • General Notices and Requirements • Guide to General Chapters-Charts • General Chapters • Reagents, Indicators, and Solutions • Reference Tables • Dietary Supplement Monographs • Official Monographs for USP • Official Monographs for NF •Combined Index
Diese neue Ausgabe USP 36 NF 31 tritt zum 1. Mai 2013 in Kraft.
Die USP NF mit mehr als 4.600 Monographien informiert Sie über Qualitätsstandards für pharmazeutische Produkte und Arzneiformen, Wirkstoffe und Hilfsstoffe, Medizingeräte und Nahrungsergänzungsmittel. Hier erhalten Sie alle Informationen, die Sie zur Identifizierung, Chargen- Freigabe, Qualitätskontrolle und für weitere wichtige Prüfungen benötigen.
Außerdem enthalten sind Hinweise zu Verpackungsvorschriften, Aufbewahrung und Kennzeichnungspflicht. Die regelmäßige Aktualisierung garantiert einen aktuellen Wissensstand hinsichtlich neuer Standards, Anforderungen und Analyseverfahren.
hard cover
Deutscher Apotheker Verlag
