Identity (pharmacy)
The correct identity of a drug in a drug is of crucial importance for its pharmacological effect and an important quality feature. The chemical or physico-chemical identification of the medicinal substance in the medicinal product serves to confirm that the correct active substance was used in production.
As a result of the identity check , there can only be one yes / no answer.
The identification of the medicinal substance is an indispensable test point in the context of the quality management of the pharmaceutical manufacturer and is legally necessary. Pharmacopoeia and licensing regulations require tests to determine the identity of the medicinal substance.
Selective or specific verification methods are essential for secure identity verification . Often, chromatographic and spectroscopic analysis methods are used, such as B.
- Thin layer chromatography in connection with several spraying methods,
- HPLC with specific detectors,
- Gas chromatography with selective detectors,
- Infrared spectroscopy (also comparison with standard spectra ) and
- Nuclear magnetic resonance spectroscopy .
Often, combinations of chromatographic and spectroscopic methods are used to check identity.
Identity of auxiliaries and dyes in the pharmaceutical industry
Auxiliaries and dyes are often also subjected to an identity check in the manufacture of pharmaceuticals. If these components are mixed up, the quality of the drug will be negatively affected, e.g. B. by a wrong color, poor shelf life , non-existent retarding effect or allergic reactions in the patient.
Individual evidence
- ^ Herbert Feltkamp, Peter Fuchs, Heinz Sucker (editors): Pharmaceutical Quality Control , Georg Thieme Verlag, 1983, pp. 689-693, ISBN 3-13-611501-5 .