Identity testing of raw materials using Lyza 7000 and Spectroscopy Suite: Active pharmaceutical ingredients
The Lyza 7000 FTIR Spectrometer, coupled with the pharma-compliant Anton Paar Spectroscopy Suite software, offers a precise and efficient solution for the analysis of raw materials, fully compliant with international pharmacopoeias. FTIR identity testing is described in this report by the example of ascorbic acid (vitamin C).
Raw material testing in the pharmaceutical industry
The pharmaceutical production, one of the world's most regulated industries, spans from raw material delivery to final product packaging. Processes must adhere to strict legal standards to ensure product quality and safety for global patients. Active Pharmaceutical Ingredients (APIs) require testing for chemical identity as per international pharmacopeias and GMP guidelines. Anton Paar’s Lyza 7000 FTIR spectrometers and Spectroscopy Suite software provide quick and reliable ID testing, with easy method development and validation, ensuring data integrity compliant with FDA's CFR 21 part 11. This report describes ID testing with Lyza 7000 and Spectroscopy Suite by the example of testing ascorbic acid (vitamin C) which is specified in Pharm. Eur. monograph 0253.
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