The development of a robust, selective, and stability indicative method for the determination of purity and or related substances is essential in the development of a new API or Drug Product.
Brightlabs has ample experience with the development of various class compounds and products, ranging from hormonal ointment to complex chiral compounds.
A method development is executed step by step, from the simple ‘proof of principle’ to a method that can be fully validated according ICH Q2 guidelines.
Secondly a forced degradation study is used to determine the stability of a drug product or drug substance, it is required to demonstrate specificity of stability indicating methods and provide insights of degradation pathways.
Download the brochure for more information about the possibilities.