Quantification and Identity Testing of Soft Gel Capsules using Transmission Raman Spectroscopy

Efficient and cost saving analytical technique requiring no sample preparation

Transmission Raman Spectroscopy (TRS) is a widely accepted technique that is used for content uniformity (CU), assay, and drug product identity (ID) testing of pharmaceutical oral solid dose (OSD) products (1,2). The Agilent TRS100 Raman pharmaceutical analysis system enables fast, non-destructive analysis of tablets and capsules, without the need for chemical preparation or skilled analytical chemists, improving the operational efficiency of quality control (QC) laboratories. The TRS100 uses transmission Raman to provide bulk volumetric analysis of OSD pharmaceutical products. The instrument can analyze active pharmaceutical ingredients (API) and excipients in a range of different sample types including tablets, powders, hard and soft gel capsules. This application note discusses how the TRS100 can be used to generate both a qualitative (ID) and quantitative analysis of soft gel capsules. The processes of calibration, model development, and method validation are also discussed.

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