Product category:
Reference standards
News Release from: Starna Scientific | Subject: Drug photostability testing kit
Edited by the Laboratorytalk Editorial
Team on 02 November 2007
Drug photostability testing complies
with ICH Q1B
Starna's drug photostability testing kit features a PTFE capped screw cap cell to avoid sample contamination difficulties
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
This article was originally published on Laboratorytalk on 14 Apr 2003 at 8.00am (UK)
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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.
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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