ICH Primer

An ICH primer

Referred to simply as the ICH guidelines, this document was prepared by the International Conference on Harmonization of Technical Requirements of Pharmaceuticals for Human Use. The US Food and Drug Administration in the Federal Register published “Guidelines for the Photostability Testing of New Drug Substances and Products” on May 16, 1997 (p. 27 116). The Guidelines recommend illumination delivering 1.2 million lux hours including 200 Watts per square meter in the UVA region. Two types of lamps are acceptable: xenon lamps (Option 1) and fluorescent tubes (Option 2). Users “may rely on the spectral distribution specification of the light source manufacturer.” Luzchem’s compliant information is supplied with LZCX-ICH1, LZC-ICH2 and CCP-ICH2 photoreactors.

We provide a mapping of the UV and VIS output and a power meter to calculated the dose supplied.  Luzchem offers an excel calculator to calculate the time required to meet the doses required by the ICH guidelines.