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Basic tests for drug substances and products

المؤلف:  Sue Jickells , Adam Negrusz (Editors)

المصدر:  Clarkes Analytical Forensic Toxicology

الجزء والصفحة:  p336-340

2026-11-01

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Basic tests for drug substances and products

The World Health Organization (WHO) has published Basic Tests for Drugs (WHO 1998), which includes pharmaceutical substances, medicinal plant materials and dosage forms. The United Nations (UN) has published Rapid Methods for Drugs of Abuse (UN 1994). The basic tests described, which are designed to verify the identity of drug substances and medicinal products and to detect gross contamination, use a limited number of readily available reagents and equipment. Overall, the combined books offer compound-specific tests for approximately 500–600 products and are based on a combination of organoleptic checks and simple physicochemical tests, such as colour reactions and melting-point determinations. Semi-quantitative TLC methods have also been developed as basic tests using a limited number of solvent systems and detection systems. References to these tests are given in WHO (1998).

It should be remembered that basic tests are not, in any circumstances, intended to replace pharmacopoeial requirements, but should be used as a rapid and inexpensive means to verify identity and strength of drugs and medicinal products, and possibly to detect poor-quality counterfeit and other substandard products. In the event that suspect products are detected, these should be tested for compliance against pharmacopoeial requirements. Given the very large number of colour tests which are available, it is beyond the scope of this textbook to list every test and the reader is referred to Clarke’s Analysis of Drugs and Poisons (Moffat et al. 2004) and to the UN Rapid Methods for Drugs of Abuse and WHO Basic Tests for Drugs for details of the various tests available. The important aspects to remember with regard to colour tests are their place in the analytical scheme (rapid, diagnostic tests) and the limitations of these tests.