ICH Stability & Photostability Studies
ICH stability study
ICH pharmaceutical stability studies are an essential component of the development and lifecycle of pharmaceutical products, in particular, supporting the development process and IND / NDA submission activities. They allow evaluation of or drug product stability under the influence of a variety of environmental factors such as temperature, humidity and light. Data from these studies enable recommended storage conditions, retest intervals and shelf lives to be established.
With a network of ICH stability storage facilities in the UK, US and Australia, we offer an extensive capacity and a range of conditions including climatic cabinets and refrigerated as well as freezer storage which are fully controlled and monitored. Our stability teams provide professionally managed Good Manufacturing Practice (cGMP) stability programs for Parenteral, Ophthalmic and Inhalation dosage form.
Our analytical laboratory network provides development and validation of stability-indicating methods utilizing a range of technologies to identify and quantify degradation products. Routine time point testing includes the usual tests such as assay ,impurity analysis and moisture,. KMS’s scientists have specialist expertise in Parenteral, testing for stability. Our know-how in extractable and leachables studies means that we can ensure that the product container/packaging system demonstrates sufficient stability over the relevant lifecycle of your product.
ICH photo stability
Light testing is an integral part of the stress testing required by the ICH Harmonised Tripartite Guideline covering the Stability Testing of New Drug Substances and Products (ICH Q1B). Two options for testing are given in ICH Q1B, with option II being preferred by most customers. Here the sample is exposed to light from two sources: a cool white fluorescent lamp and a near ultraviolet lamp, with results being expressed in terms of exposure in lux hours and watt hours per square metre.
The chamber installed at KMS is validated for optimum homogeneity of both types of light source, ensuring that all samples receive the same radiation doses, and it is temperature and humidity controlled to ensure that all degradation results are attributable to photostability rather than impacts from other variables. It is suitable for forced degradation study, the fully exposed product, the product in the immediate package and the product in the marketing package as required.