Discover essential principles and methodologies for photostability testing in compliance with ICH guidelines. Learn about light source selection, procedural insights, and strategies for testing drug substances and products effectively.
Explore the ICH Harmonized Tripartite Guideline and get informed about key photostability testing principles and methodologies.
ICH Guidelines Explained
Already the ICH Harmonized Tripartite Guideline says that it is important to perform a preliminary assessment of new drug substances and products. The document details a stepwise strategy for photostability testing, including drug substance and representative drug product container-closure stage tests. BioBoston Consulting supports the registeration applications with photostability data in compliance with these guidelines accurately
Selecting The Right Lights
Choice of light sources is one of the most critical parts of photostability testing. Whether choosing artificial daylight fluorescent lamps or cool white fluorescent and near ultraviolet (UV) lamps, it is important to know the spectral distribution specifications. Our specialists help clients with temperature guidance and dark controls to ensure consistent testing results.
Procedural Insights
Verification studies are crucial projects where samples are subjected to particular lighting and UV vitality. The tips of our consultants to use validated chemical actinometric systems and performances with calibrated radiometers / lux meters will provide insights into how the process works as accurately as possible.
Drug Substance Testing
We also propose a two-phase testing strategy, forced and confirmatory degradation of drug substances. Knowledge on forced degradation testing helps in developing test methods and finding out degradation pathways. . Our firm assists drug product manufacturers with presentation of the samples to be analyzed, prior to testing and we offer advice on the containers (primary packaging) appropriate for each state of the drug substance.
Drug Product Testing
Drug product testing is guided through a sequential manner, from products fully exposed to those in retail/ marketing packs. BioBoston Consulting asess the need for photostability characteristics control tests on representative batches in context and offers a path forward when more tests may be needed.
Our internalization of ICH guidelines and systematic process enables us to guide our clients through the regulatory demands with a certainty.
Learn more about how we can assist your organization. Contact BioBoston Consulting
