Pharmaceutical raw materials are substrates or elements used for manufacturing different drug products. Raw materials include active pharmaceutical ingredients (API), excipients, and other inactive ingredients. Excipients and inactive ingredients generally have no pharmacological effect, yet they are essential components that function as fillers, binders, disintegrants, lubricants, coloring agents, and preservatives.
In this application note, we present a robust and quick UPLC method for analysis of cetrimonium bromide raw material. This methodology was developed in partnership with Genzyme A Sanofi Company. The UPLC method utilizes an ACQUITY QDa Detector for fast, information-rich, and accurate assessment of quality and purity of raw materials. We demonstrate the system suitability and linearity of the method achievable with mass detection. This method was then used to confirm identity of, assess purity of, and assay cetrimonium bromide raw material purchased from three different suppliers.
Overall, the ACQUITY QDa Detector is a robust and simple-to-use mass detector that can be added as an orthogonal detection technique to the UV detection. It provides accurate and reliable results, making this technology ideal for routine testing of pharmaceutical raw materials in the QC laboratory.