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New drug photostability testing kit
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Complies with ICH Q1B regulations
A new, easy-to-use Drug Photostability Testing Kit has been launched by Starna Scientific to address the pharmaceutical industry’s stringent drug evaluation requirements.
The kit has been specially designed to comply with International Conference of Harmonisation’s Q1B |
stability testing guidelines that state light testing should be an integral part of stress testing.
The ICH Q1B guidelines call for the intrinsic photostability characteristics of new drug substances and products to be evaluated to demonstrate that, as appropriate, light exposure does not result in unacceptable change.
Starna’s Drug Photostability Testing Kit features a PTFE capped screw cap cell to avoid sample contamination difficulties. The cell’s construction ensures the test material only contacts inert materials such as PTFE or glass.
The use of capped cells improves the measurement process by helping to avoid the transfer step from ampoule to cuvette.
The Starna kit is supplied in a ‘light exclusion’ storage box and comprises of 4x matched cells (1/GL14/PX/10) that features all the components necessary to successfully carry out drug photostability evaluations. The kit includes 2x cells (Sample and Reference) for test substance, and 2x cells (Sample and Control) for Quinine Chemical Actinometry as well as comprehensive Standard Operating Procedure (SOP) documentation. |
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