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World Health Organization : Year 2001 ; World Health Organization, Department of Essential Drugs and Other Medicines, Quality of Self-Medication 2001.2: Reference Substances and Infrared Reference Spectra for Pharmcopoeial Analysis January 2001

By World Health Organization

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Book Id: WPLBN0000138538
Format Type: PDF eBook
File Size: 6.8 MB
Reproduction Date: 2005
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Title: World Health Organization : Year 2001 ; World Health Organization, Department of Essential Drugs and Other Medicines, Quality of Self-Medication 2001.2: Reference Substances and Infrared Reference Spectra for Pharmcopoeial Analysis January 2001  
Author: World Health Organization
Volume:
Language: English
Subject: Health., Public health, Wellness programs
Collections: Medical Library Collection, World Health Collection
Historic
Publication Date:
Publisher: World Health Organization

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Organization, W. H. (n.d.). World Health Organization : Year 2001 ; World Health Organization, Department of Essential Drugs and Other Medicines, Quality of Self-Medication 2001.2. Retrieved from http://hawaiilibrary.net/


Description
Medical Reference Publication

Excerpt
The purpose of having reference substances and infrared reference spectra is to achieve accuracy and reproducibility of analytical results required by pharmacopoeial testing and pharmaceutical control in general. These substances and infrared spectra are normally prepared and issued by the regional/national pharmacopoeial commission or the regional/national quality control laboratory on behalf of the drug regulatory authority. The general use of a reference substance or an infrared reference spectrum should be considered as an integral part of a compliance-oriented monograph or test procedure used to demonstrate the identity, purity and content of pharmaceutical substances and preparations. The establishment of reference substances should be based on reports in which the results of analytical testing have been evaluated. These reports should be subsequently approved and adopted by a certifying body, normally the relevant pharmacopoeial committee or the drug regulatory authority. Such establishment can be on an international, national or regonal basis. Each substance is generally established for a specific analytical purpose, defined by the issuing body. Its use for any other purpose becomes the responsibility of the user and a suitable caution is included in the information sheet accompanying a reference substance.

Table of Contents
Contents Preface 3 1. Compilation of national, regional and international reference substances and infrared reference spectra 5 1.1 Reference substances for pharmacopoeial analysis 5 Addresses for the purchase or the source of reference substances 5 List of reference substances 9 1.2 Infrared reference spectra for pharmacopoeial analysis 103 Addresses for the purchase or the source of reference spectra 103 List of reference spectra 105 2. General guidelines for the establishment, maintenance and distribution of chemical reference substances 126 Reprint from WHO Technical Report Series, No. 885, 1999: Annex 3

 

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