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Carbogen Amcis Boosts Stability Capabilities

ICH compliance enhances stability offerings

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Carbogen Amcishas enhanced its stability chambers in compliance with the latest International Conference on Harmonization (ICH) guidelines. According to the company, the move boosts its service portfolio for stability studies: short-term, long-term, accelerated, intermediate, follow-up and customized tests.

The company’s new fully validated and mapped stability chambers operate at ICH conditions (25°C/60% RH, 30°C/65% RH, and 40°C/75% RH) and at low temperatures (5°C, -20°C and -80°C). With an increased shelf storage capacity of about 92 m2, they provide secure and safe storage for API samples, including high potency material, employed for in-house stability studies.

“The completion of new state-of-the-art stability chambers strongly enhances Carbogen Amcis’ service portfolio and confirms our ongoing commitment in providing our customers with the best innovative, timely and safe drug development solutions,” said Mojmir Vavrecka, Carbogen Amcis’ chief executive officer. “We are facing an increasing customer demand for stability studies tied to our API development and production efforts. This expansion meets our customers’ needs.”

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