Counterfeit Drugs
(1999; 61 pages) [French] [Spanish] View the PDF document
Table of Contents
View the documentExecutive Summary
Open this folder and view contents1. Introduction
View the document2. Overview of the problem
View the document3. Impact on public health
View the document4. Factors facilitating counterfeiting
Open this folder and view contents5. Developing national strategies
Open this folder and view contents6. Specific measures
Open this folder and view contents7. Assessment of the problem at the national level
Open this folder and view contents8. Inspection when pharmaceutical products are suspected to be counterfeit, spurious or substandard
Close this folder9. Test methods
View the document9.1 Methods based on thin-layer chromatography
View the document9.2 Other simple methods
View the document9.3 Analytical techniques
View the document9.4 Visual inspection
View the document9.5 Successful implementation of simple tests
Open this folder and view contents10. Developing training programmes: inspection and examination of counterfeit pharmaceuticals
View the document11. Conclusion
View the documentReferences
View the documentSelected further reading
View the documentAcknowledgements
View the documentGlossary
 

9.1 Methods based on thin-layer chromatography

TLC screening procedures are recommended for the detection of counterfeit drugs. Numerous studies have demonstrated the multiple uses of these methods. They can be employed for the identification of drug substances, the estimation of drug substance content and the detection of related substances which could be regarded as impurities. TLC procedures are more specific and selective than WHO basic tests for the identification of drug substances (see section 9.2) and are also subject to less interference by excipients.

A counterfeit product may contain the correct active ingredients but in amounts other than those declared. In response to effective anticounterfeit measures, counterfeiters have often introduced small quantities of the genuine pharmaceutically active substances into the dosage forms. This gives positive identification results and in this way counterfeiters attempt to foil or confound the process of detection. In such cases, the basic tests are inadequate; TLC procedures are therefore preferred, as they are capable of giving semi-quantitative information on the active ingredient and also on any related substances in the dosage forms.

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Last updated: May 3, 2013