Photostability tests according to ICH Q1B standard
Photostability testing is defined by the ICH (International Conference on Harmonisation) guidelines, under the Q1B guideline: Photostability testing of new active substances and medicinal products.
Photostability tests are an important part of the R&D activities in the quality control of products or chemical substances in the cosmetic, chemical, food and pharmaceutical industries.
It's main objective is to certify the preservation of pharmaceutical products under certain storage conditions.
To do this, they evaluate the stability of a product against light to confirm that it does not change in an unacceptable way.
ICH guidelines are a set of guidelines to ensure the safety , efficacy and quality of medicines are developed and registered efficiently. This is a common project of regulatory authorities and the pharmaceutical industry from Europe, the United States and Japan, where most new medicines are developed.. They are an essential part of the authorization and registration of a product, as no product can be commercialised without passing the stability study.
The guideline that defines and sets out the recommendations for Photostability testing is ICH Q1B (Photostability testing of new active substances and medicinal products). The guideline provides advice on the photostability information to be submitted in the marketing authorization application for new active substances and associated medicinal products.
Photostability chambers are intended to provide evidence on how the quality of a medicine varies over time under the influence of a variety of environmental factors such as temperature, light and humidity, and thus the shelf life of medicine.
References:
QuimiNet. 2022. ¿Cuál es la importancia de la fotoestabilidad en productos y sustancias químicas?. [online] Available at: <https://www.quiminet.com/articulos/cual-es-la-importancia-de-la-fotoestabilidad-en-productos-y-sustancias-quimicas-23108.htm> [Accessed 19 September 2022].
European Medicines Agency. 2022. ICH: quality - European Medicines Agency. [online] Available at: <https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-guidelines/ich/ich-quality> [Accessed 19 September 2022].
