Transform your End-Product Testing- Quantification of Tablets Containing Multiple APIs Using Transmission Raman Spectroscopy

The ability to predict multiple constituents of a final dosage form in one fast, nondestructive measurement can reduce analysis time and cost significantly. This is especially beneficial when quantification of multiple active pharmaceutical ingredients (APIs) is required for tests such as content uniformity, assay, and identity (ID). This example, based on a common cold and flu product, demonstrates the quantification of five components (three APIs and two excipients) with a nine‑second measurement. Nominal concentrations for the APIs ranged from 1 to 85 % w/w.

Typical solid dose forms of a drug product contain at least one active pharmaceutical ingredient (API) and a range of excipients at varying levels. The most widely used means of quantitative analysis is high-performance liquid chromatography (HPLC), which is often the standard reference technique. HPLC is highly capable; however, sample preparation is resource intensive, consumables are needed and analysis takes time to complete. This formulation requires a different separation step and analytical test for the phenylephrine component, and HPLC is not commonly used for excipient analysis. Transmission Raman spectroscopy (TRS) is a regulatory‑acceptable alternative technique for content uniformity, assay, and drug product identity, enabling fast, nondestructive analysis of tablets and capsules without chemical preparation or skilled analytical chemists.

A TRS100 system can reduce content uniformity, assay, and ID tests to minutes per batch, saving significant cost and speeding up your quality control workflow. Sample preparation and consumables are not needed, meaning skilled analytical resource is not required. Content uniformity testing methods using transmission Raman have been approved by regulators using ICH and regulatory-authority acceptable protocols.

Agilent TRS100 Raman – Streamlined Quality Control:

• Fast – Test hundreds of intact tablets or capsules in minutes
• Simple – Quantify active pharmaceutical ingredients (APIs) and polymorphs in a single measurement
• Low cost – No need for sample preparation, consumables, or skilled testing resource
• Compliant – Regulatory approved methods for content uniformity, assay, and identification

Download application note and connect with Agilent representative to know how TRS 100 can save hours of testing.