Content uniformity testing is a standard pharmaceutical test to ensure the active pharmaceutical ingredient (API) content in solid dosage forms of pharmaceutical products. It ensures that compressed tablets that reach the consumer have the correct and safe amount of the (API). The U.S. Pharmacopeia and the European Pharmacopeia both have chapters which regulate this testing (USP <905> and EP 2.9.40).The QTRam® is a compact transmission Raman analyzer and is designed specifically for content uniformity analysis of finished products such as tablets and capsules.
Transmission Raman samples a larger volume of the sample, and the Raman signal is transmitted and diffuses through the sample body. This transmittance through the sample allows for a more accurate and representative measurement of the sample in comparison to conventional Raman which is more of a surface measurement.
Content uniformity is mandated testing that is typically done with high-performance liquid chromatography (HPLC). HPLC separates a mixture of compounds using column chromatography to identify, quantify or purify the components of the mixture; the drawback of HPLC is it is time-consuming, destructive and generates wastes. Transmission Raman can do content uniformity testing in a rapid, nondestructive manner and can quantify multiple components from a single spectrum. With step by step easy to follow quantitative method development, Raman can readily be adopted for in-process and final product QC testing.
The portable Transmission Raman Spectrometer QTRam® device powered by patented STRaman® technology is optimized for rapid and nondestructive quantitative analysis. It is ideal for content uniformity testing and also aids in formulation development, quality by design (QbD) initiatives and counterfeit detection.