Eliminate sample preparation from Content Uniformity Testing
Conventional drug product batch testing for content uniformity is time and effort intensive. Is there a better way?
Traditional Content Uniformity(CU) testing involves lengthy sample preparation which takes up huge amounts of time, resources and costs. Transmission Raman Spectroscopy (TRS) is a non-destructive, bulk analytical technique which eliminates the need for sample preparation. TRS can save days or even weeks of QC testing. TRS is ideal for quantitative measurements of oral solid dose forms, such as tablets and capsules. TRS is a regulatory approved technique for batch release testing. Find out all the applications and benefits of TRS.
Relieving the Test Burden—Utilizing Transmission Raman Spectroscopy in Small Molecular Oral Solid Dose Manufacturing
Watch this video to find out how to relieve the test burden in oral sold dose (OSD) manufacturing. We present the TRS100 for mandatory batch release tests. The TRS100 can help with ID Assay and Content Uniformity since these tests show the highest test burden in the QC lab. The streamlined analytical workflow addresses market demands of cost saving, sustainability, and innovation. It provides a high throughput, a bulk analytical technique that doesn't require sample preparation, making it a faster approach that frees up the analytical laboratory, enabling you to test more.
Eliminate Sample Prep and Reduce QC Testing by Days or Weeks
Transform your pharmaceutical end-product testing. TRS is ideal for quantitative measurements of oral solid dose forms, such as tablets and capsules. The technique complements HPLC, UV-Vis, and other traditional analytical techniques for CU testing.
DownloadQuantification of Tablets Containing Multiple APIs Using Transmission Raman Spectroscopy
This application note demonstrates that multiple APIs in a single intact tablet can be quantified easily by TRS. The time taken for content uniformity, assay, and identity was reduced from approximately two days (by chromatographic methods) to less than five minutes for a batch of 10 tablets and does not require skilled analytical resources for routine testing.
DownloadQuantification and Identity Testing of Soft Gel Capsules using Transmission Raman Spectroscopy
The study has shown that the Agilent TRS100 Raman quantitative pharmaceutical analysis system is suitable for soft gel capsules' content uniformity, assay, and identity testing. The method was fast, requiring only 10 seconds of measurement time, and no sample preparation, solvents, chemicals, or consumables were needed. Given the simplicity and speed of the method, the TRS100 provides an efficient, cost-effective, and sustainable workflow for QC testing of soft gel capsules.
DownloadQuantification of Crystallinity Using Transmission Raman Spectroscopy
The crystallinity of an active pharmaceutical ingredient (API) may affect its bio‑availability and its overall patient efficacy. It is critical to be able to measure the crystalline content of a final drug product. TRS can differentiate and quantify crystalline and amorphous API. Measurements are fast, and the transmission sampling geometry ensures that the signal obtained is representative of the bulk and not biased to the surface.
DownloadQuantitative Analysis of Warfarin Tablets Containing Salt-Form Impurities Using Transmission Raman Spectroscopy
This application note demonstrates the use of TRS for the quantification of Warfarin in whole intact pharmaceutical tablets at 0.5 % w/w with 20-second measurement time1. TRS can differentiate between and quantify two forms of Warfarin without sample preparation. Traditional chromatography techniques cannot do this as the form information is destroyed by solvation. TRS enables fast, automated, non-destructive quantitative bulk analysis of pharmaceutical oral solid dose forms for content uniformity and polymorph analysis.
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