The identification and qualification of impurities and/or degradants is critical in terms of product efficacy and safety. Regulatory bodies, such as the FDA and ICH, have established clear and rigorous guidelines for setting thresholds for the reporting, identification, and qualification of impurities in drug substances and drug products.
Stress testing is an important aspect of the drug development process. Appropriate stress testing can greatly aide the elucidation of forced degradation pathways. Recent efforts by the ICH with regard to stability testing have brought increased regulatory scrutiny of impurities and the need to identify and qualify impurities at lower levels.
Controlling degradation‐related impurities involves identifying which of the potential degradation products found during stress testing actually form in either the drug substance or product under long‐term or accelerated storage conditions and then selecting the appropriate measures to minimize the impurities or degradants.
Quantex Laboratories offers comprehensive impurities testing for both small and large molecule drug products and medical devices. Our laboratories can carry out impurity profiling studies by the forced degradation of samples providing insight into potential degradion pathways and their potential impact on pharmaceutical development. Degradant related impurities can be characterized or identified by performing degradation studies under acidic, basic, oxidative, and various heat and light conditions. Degradant products can be identified by LC/MS, LC/MS/MS, GC/MS, as well as other techniques.
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