Transmission Raman Technology for Analysis of Low-Dose Pharmaceutical Tablets

B&W Tek's QTRam Portable Raman Analyzer for Content Uniformity Analysis

Compressed tablet is the most common form of orally administered drug. The United States Pharmacopeia (USP) chapter <905> requires that dosage uniformity of such products containing less than 25 mg or less than 25% active pharmaceutical ingredients (API) by weight must be analyzed for content uniformity, which is based on the assay of each API in a number of individual dosage units. Traditional wet chemistry methods such as titration or HPLC require complete dissolution of the tablets in suitable solvents, which destroy the samples, create waste, and can be labor intensive and time consuming. Vibrational spectroscopic techniques, notably NIR absorption and Raman scattering, are nondestructive, fast, and require no consumables. Transmission Raman Spectroscopy (TRS) is particularly promising due to its ability to sample a large portion of the sample’s volume.

QTRam® is a compact transmission Raman analyzer designed specifically for content uniformity analysis of pharmaceuticals in solid dosage forms. In this note, we use a model drug, acetaminophen, to demonstrate the capability of QTRam® to quantify low concentrations of API in compressed tablets.