WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 863 - Thirty-fourth Report
(1996; 200 pages) View the PDF document
Table of Contents
View the document1. Introduction
Open this folder and view contents2. The international pharmacopoeia and related activities
View the document3. Simple test methodology
Open this folder and view contents4. Stability of dosage forms
Open this folder and view contents5. Good manufacturing practices for pharmaceutical products
Open this folder and view contents6. Legal and administrative aspects of the functioning of national drug regulatory authorities
Open this folder and view contents7. Quality assurance in the supply system
View the document8. Terminology
View the documentAcknowledgements
View the documentReferences
Open this folder and view contentsAnnex 1 - Guidelines for the graphic representation of chemical formulae
View the documentAnnex 2 - List of available International Chemical Reference Substances1
View the documentAnnex 3 - List of available International Infrared Reference Spectra
Close this folderAnnex 4 - General recommendations for the preparation and use of infrared spectra in pharmaceutical analysis
View the document1. Introduction
View the document2. Apparatus
View the document3. Method of verification of frequency scale and resolution
View the document4. Environment
View the document5. Use of solvents
View the document6. Preparation of the substance to be examined
View the document7. Identification by reference substance
View the document8. Identification by reference spectrum
View the document9. Reflectance techniques
Open this folder and view contentsAnnex 5 - Guidelines for stability testing of pharmaceutical products containing well established drug substances in conventional dosage forms
Open this folder and view contentsAnnex 6 - Good manufacturing practices: guidelines on the validation of manufacturing processes
Open this folder and view contentsAnnex 7 - Good manufacturing practices: supplementary guidelines for the manufacture of investigational pharmaceutical products for clinical trials in humans
Open this folder and view contentsAnnex 8 - Good manufacturing practices: supplementary guidelines for the manufacture of herbal medicinal products1
Open this folder and view contentsAnnex 9 - Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability
Open this folder and view contentsAnnex 10 - Guidelines for implementation of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
Open this folder and view contentsAnnex 11 - Guidelines for the assessment of herbal medicines1,2
Open this folder and view contentsAnnex 12 - Guidelines on import procedures for pharmaceutical products
View the documentBack Cover
 

1. Introduction

In pharmaceutical analysis the region of the electromagnetic spectrum used is 4000-600 cm-1 (wavelength 2.5-16.7 µm), i.e. the mid-infrared. Spectrophotometric measurements in this region are mainly used for identification purposes. Except for enantiomers, which have identical spectra in solution, the infrared spectrum of any given substance is unique. Polymorphism and other factors, such as variations in crystal size and orientation, the grinding procedure, and the possible formation of hydrates may, however, be responsible for minor, and occasionally substantial, variations in the infrared spectrum of a substance in the solid state. The infrared spectrum is not usually greatly affected by the presence of small quantities of impurities in the substance tested. For identification purposes, the spectrum may be compared with that of a reference substance, concomitantly prepared, or with a reference spectrum.

The terms absorbance, transmittance, absorptivity and absorption spectrum are defined in The international pharmacopoeia, 3rd ed., Vol. 1, pp. 33-34, in the chapter "Spectrophotometry in the visible and ultraviolet regions".

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Last updated: May 3, 2013