appendices of USP pharmacopeia.gfdfgdghdghpptx

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United States pharmacopoeia Appendices

Submitted to : Ma’am sana shahzad Submitted by: Amna Farooq DPH-fa16-009

Pharmacopoeia, Monogragh A n official publication containing a list of medicinal drugs with their effects and directions for their use. A pharmacopeia , (“drug-making standard ”), is a book containing directions for the identification of compound medicines. The usp Is a pharmacopeia for the United States published annually by the United States pharmacopeia. A monograph published in any USP compendium (in a book CD-ROM or on line) provides the name of substance, it’s definition, package, storage and labeling requirements and information on tests needed to ensure the substance of the appropriate strength, quality and purity.

United States pharmacopeia The United States Pharmacopoeia (US P) is the national pharmacopoeia . It is an annually published collection of quality standards for United States medicinal substances. It is a non-profit organisation that owns the trademark and copyright. Latest edition: The current version of USP-NF standard deemed official by USP. Food and drug adminstration for medicine manufactured in United State. A new addition with 2016 standard--USP 40-NF 35—becomes official August 1,2017.

Editions of United States pharmacopeia 1820 The USP pharmacopeial conversation founded in Washington DC. Usp creates a system of standard and a national Formulary. Only 217 drugs meeting the criteria of most fully established and best understood. 1830 Committee of revision created and this revision continue at 10year interval.

Cont…….. 1848 Drug import Act passed. Faderal legislation recognizes the USP as an official compendium. 1850 Colleges of pharmacy invited to participate in revision of USP. 1880 Chairman of committee of revision initiate effort to modernise USP. Monograph and methods 1888 Ist national pharmulary (NF) published by Americans Pharmacist association.

Cont……… 1963 Ist United State Adopted Names (USAN) commutative list published 1964 USAN council formed by American medical association and Americans Pharmacist association (APhA). 1975 USP acquire national Formulary and drugs standard laboutary from APhA.

Cont… 1990 USP members adopt a resolution to explore establishing standard for vitamin and minerals. 1995 USP member adopt a resolution to explore establishing standard for botanical dietary supliments. 2001 USP launches the dietary supliments verification program. 2002 The USP-NF published annually. 2009 Ist Russian addition of USP-NF published.

Cont…. 2012 USP hosts the pharmacopeial decisions for the 1 st time at the USP-US.USP-NF translated into Chinese. 2013 USP in produce a new logo to empathize the global scope of pharmacopeia.

Volumes USP printed in three volumes Volume 1: Contains general chapters. Volume 2 and 3: Containes monographs.

Appendices and indices Appendix 1: Apparatus for Test and Assays. Appendix 2: Physical Tests and Determinations. Appendix 3: Chemical Tests and Determination. Appendix 4: Chewing Gum Base. Appendix 5: Enzymes Assays. Appendix 6: Essential Oils and Flavors. Appendix 7:Fats and Related Substances. Appendix 8: Olioresions. Appendix 9: Rosins and Related Substances. Appendix 10: Carbohydrates. Appendix 11: Flavor Chemicals

Cont……… Appendix 12: Microbiological Tests Appendix 13: Adulterants and Contaminants in Food Ingredients Appendix 14: Markers for Authenticity Testing

United States pharmacopoeia 34- National Formulary 29 It contains more then 4500 monographs for drug substances, dosage form, excipients, biological, dietary supplements and other therapeutics. USP 34-NF 29 also offers harmonized material. More then 230 general chapters with current guidelines for the full range of labotary tests. Established processes for validation method.

United States pharmacopoeia 35-National formulary 30 It is a combination of two official compendia the United States pharmacopoeia (USP) & National Formulary(NF) and is officially applicable from may,2012 to 20 April 2013

United States pharmacopoeia Usp 23 has ten supplements. First supplement was published in January 1995 ana last in May 1999. USP24-NF19, appeared from first January 2000. USP30-NF25, appeared from may 2007. It contains scientific standards for drugs , dietary substances, biological products and excipients used in dosage form. It contains 4100 monographs and 200 general chapters.

United States pharmacopoeia 30-National formulary 25 New heavier paper stock. Complete table of contents and index in each volume. Special Using the New USP-NF Print tutorial CD. Convenient slipcase for easy access and storage (English eddition only).

United States pharmacopoeia 31 formulary 26 The USP-NF is a single volume combination of two official compendia the United States pharmacopoeia (USP) National formulary (NF). Monographs for drug substances and preparations are featured in the USP with monographs for dietary supplements and ingredients appearing in a separate section of USP. Excipient monographs are included in NF.

United States pharmacopoeia 32- National Formulary 27 It contains More then 4200 monographs. Includes over 200 general chapters, covering general test and assays. Includes information on emerging areas of science and medicine. Help ensure compliance with official standards. Creates in-house standards for operating procedures and specifications. Expedite new product development and approvals.

United States pharmacopoeia 33- National Formulary 28 More then 4400 monographs. Over 200 general chapters covering general test and assays. A new , easy to read format and monograph layout. Helpful guide and charts that make it easy to find focus specific information. Ensures compliance with official standards. Established in house standards operating procedure and specifications Facilities new product development and approval.
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