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Transmission Raman Method Gains Regulatory Approval for Content Uniformity Batch Release Test

Cobalt Light Systems is pleased to announce that a major pharmaceutical company has gained regulatory approval to release products using Cobalt’s TRS100 instrument instead of by HPLC. This is a landmark achievement in reducing the industry’s dependence on the expensive and time-consuming “workhorse” technique of High Performance Liquid Chromatography (HPLC). The content uniformity (CU) test assesses whether all of the tablets in a manufactured batch contain the right amount of active ingredient, so is a crucial regulated test for determining product safety.

HPLC is the industry’s “go-to” technique for CU testing, but it has significant disadvantages. As well as taking hours per test it requires a trained chemist, solvents and other consumables, a sample preparation step and is limited by the throughput of a quality control laboratory. Typically, only 10 tablets from a batch of perhaps millions of tablets are tested – for larger sample sizes the time taken would be prohibitive by HPLC. The TRS100 can test 100-200 tablets or capsules in one measurement run in 20-40 minutes – an HPLC equivalent might take several days to complete that many, at a significantly high cost. The TRS100 performs a complete CU test in a few minutes – less than 10 seconds per tablet or capsule – saving typically around $500 per batch test.

Transmission Raman spectroscopy has many advantages and is under evaluation at many pharmaceutical companies as a means to improve quality and reduce costs. The HPLC market for pharmaceutical companies is worth approximately $1.1Bn, of which 60% is the cost of consumables, such as solvents and columns. By removing the ongoing costs, skill requirements and operator variability of HPLC, transmission Raman can significantly increase the throughput and quality of a QC laboratory. Cobalt’s Business Development Director, Darren Andrews, said, “Transmission Raman is a fantastic fit for this application and gaining regulatory approval to use it as an alternative to HPLC removes a perceived barrier to the industry’s more wide-spread adoption. I expect significant growth for TRS in this area as more approvals are expected soon.”

  • A Cobalt webinar discusses the approach to achieving successful registration and interpretation of current regulatory guidance.

To enquire about the TRS100 instrument or capabilities contact Cobalt Light Systems or +44 (0)1235 856 555. Alternatively, contact your local representative.

About Cobalt Light Systems Ltd.

Cobalt Light Systems develops products and technology for non-invasive analysis. Cobalt addresses several markets with unique instruments for security, pharmaceutical and research industries. Cobalt was established in 2006 to develop its novel technologies into a range of Raman applications for laboratory and industrial analysis. The underlying technology is exclusive to the company and was invented at the Science and Technology Facilities Council’s Rutherford Appleton Laboratory in the UK.