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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 Pressure 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.”

An upcoming live webinar on the 10th December will discuss the approach to achieving successful registration and interpretation of current regulatory guidance. See website for details

To enquire about the TRS100 instrument or capabilities contact Cobalt Light Systems [email protected] or +44 1235 856 555. Alternatively, contact your local representative

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