Identity Testing of Raw Materials using Raman Spectroscopy: Precursor and API related Substances

Cora 5001 together with the pharma compliant Spectroscopy Suite desktop software is a fast tool for identity testing of precursor and API related substances. Method development and validation according to USP regulation is easily possible.

The pharmaceutical production industry is one the most heavily regulated markets in the world. From the delivery of raw materials to the packaging of final products, the production processes need to be monitored according to legal requirements ensuring product quality and minimizing risks for the patients in all parts of the world. The Active Pharmaceutical Ingredients (APIs), the pharmacologically active part of a drug product, need to be tested among other things for their chemical identity as stated by international pharmacopeias and GMP guidelines. In addition, drug formulations may include precursors or API related substances such as degradation products if there were e.g. problems during production procedure or storage. Here, fast and accurate methods are required to quickly assess whether a batch is fit for further use or needs to be rejected. Anton Paar’s Cora 5001 Raman spectrometers together with the Spectroscopy Suite desktop software offer fast and reliable ID testing using algorithmic database matching. Method development and validation are straightforward and processes are easy to handle due to the intuitive user interface. As the software is fully compliant to CFR 21 part 11 according to FDA, data integrity and a complete audit trail are ensured.

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