Impurities
Impurities Method Development, Validation, and Testing
Regulatory bodies around the world require testing for and monitoring of impurities related to the active ingredient. The active pharmaceutical ingredient (API) can degrade into related substances that form during storage of the bulk API or the drug product. Each known and unknown related substance must be detected and monitored throughout the drug development cycle with specifications set for clinical trial material and commercially approved products.
At Vici Health Sciences, we have the knowledge and experience in reaction chemistry, analytical chemistry, formulation science, and global regulatory requirement to develop and validate such test methods. We can also perform R&D and cGMP testing on your drug substance and products. We offer HPLC-based impurity and related substances method development, validation, and testing. Our HPLC capabilities include:
- HPLC UV detectors
- HPLC PDA detectors (photo diode array)
- HPLC RI detectors (refractive index)
- Ion chromatography (Dionex ion chromatography system) to detect ions that do not have chromophores for UV detection
Vici uses ICH stability chambers to perform shelf-life studies and testing on your product needed for both clinical trial material and commercial supplies.
Known or unknown-related substance or degradant exceeding specifications are less than ideal and are generally challenging to resolve, putting drug development programs back months, even years. As your end-to-end R&D service provider, Vici can guide you on what your options are and how to potentially mitigate risk in these situations.