¹ This document is an update of the former document series WHO/PHARM/95.575.

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 regional 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.

The general guidelines for the establishment, maintenance and distribution of chemical reference substances describe the general practice to establish, maintain and distribute both primary and secondary chemical reference substances. The preparation of a chemical reference substance should comply with the requirements for quality assurance systems, including principles of good manufacturing practices (GMP) and good practices for national pharmaceutical control laboratories (GPCL). Adequate training programmes are also required. Both the WHO Collaborating Centre and other laboratories concerned with the evaluation and establishment of chemical reference substances give assistance in training.

REFERENCE SUBSTANCES FOR PHARMACOPOEIAL ANALYSIS

The following list provides current information, availability and sources of reference substances for pharmacopoeial analysis. The list is also available on the World-Wide Web accessible through http://www.who.int/dmp/icrs.html.

INFRARED REFERENCE SPECTRA FOR PHARMACOPOEIAL ANALYSIS

The following list provides current information, availability and sources of infrared reference spectra for pharmacopoeial analysis. The list is also available on the World-Wide Web accessible through http://www.who.int/dmp/irspectra.htm.

_________________________________

WHO is not in a position to sell, or reply to any requests concerning, the reference materials mentioned in this document. Requests may be routed to the addresses supplied on the following pages.

The lists will be updated on a regular basis, and we should welcome any observations or additional data which you feel would complete the information contained in this document. Please address any comments to:

Quality Assurance & Safety: Medicines
Essential Drugs and other Medicines
World Health Organization
1211 Geneva 27, Switzerland
Fax: (0041 22) 791 47 30
E-mail: koppkubels@who.int