WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 885 - Thirty-fifth Report
(1999; 168 pages) [Spanish] View the PDF document
Table of Contents
View the documentWHO Expert Committee on Specifications for Pharmaceutical Preparations
View the document1. Introduction
Open this folder and view contents2. The international pharmacopoeia and related issues
Open this folder and view contents3. International Chemical Reference Substances and Infrared Reference Spectra
Open this folder and view contents4. Quality control - national laboratories
Open this folder and view contents5. Good manufacturing practices
Open this folder and view contents6. Quality systems and inspection
Open this folder and view contents7. Other quality assurance topics
Open this folder and view contents8. Nomenclature and terminology
Open this folder and view contents9. Legal aspects of pharmaceuticals
Open this folder and view contents10. Regulatory issues
Open this folder and view contents11. Training activities
View the document12. Pharmaceuticals contaminated with diethylene glycol
View the documentAcknowledgements
View the documentReferences
View the documentAnnex 1. List of available International Chemical Reference Substances1
View the documentAnnex 2. List of available International Infrared Reference Spectra1
Close this folderAnnex 3. General guidelines for the establishment, maintenance and distribution of chemical reference substances
View the documentIntroduction
Close this folderPart A. Primary chemical reference substances
View the document1. Assessment of need for the establishment of chemical reference substances
View the document2. Obtaining source material
Open this folder and view contents3. Evaluation of chemical reference substances
Open this folder and view contents4. Chemical and physical methods used in evaluating chemical reference substances
View the document5. Assignment of content
Close this folder6. Handling and distribution of chemical reference substances
View the document6.1 Packaging operations
View the document6.2 Storage
View the document6.3 Stability
View the document6.4 Information to be supplied with chemical reference substances
View the document6.5 Distribution and supply
View the document6.6 Period of use
View the documentPart B. Secondary chemical reference substances
View the documentReferences
Open this folder and view contentsAnnex 4. Good manufacturing practices: authorized person - role, functions and training
Open this folder and view contentsAnnex 5. Good manufacturing practices: supplementary guidelines for the manufacture of pharmaceutical excipients
Open this folder and view contentsAnnex 6. Guidelines for inspection of drug distribution channels
View the documentAnnex 7. Good pharmacy practice in community and hospital pharmacy settings
Open this folder and view contentsAnnex 8. National drug regulatory legislation: guiding principles for small drug regulatory authorities
Open this folder and view contentsAnnex 9. Provisional guidelines for developing training programmes: inspection and examination of counterfeit pharmaceuticals
View the documentWorld Health Organization Technical Report Series
View the documentSelected WHO Publications of Related Interest
View the documentBack Cover
 
6.2 Storage

Information about suitable storage conditions can often be obtained from the manufacturer of the source material and should be requested routinely when a new chemical reference substance is established. Theoretically, the stability of the substances should be enhanced by keeping them at low temperatures but, for substances that contain water, storage below 0°C may impair the stability. It should also be remembered that the relative humidity in normal refrigerators or cold-rooms may be high and, unless ampoules or other tightly closed containers are used, the improvement in stability may be more than offset by degradation due to the absorption of moisture. Storage at about +5°C, with precautions to prevent such absorption, has proved satisfactory for most chemical reference substances.

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