Regardless of whether release testing or stability testing, regardless of whether synthetic or herbal drugs or raw materials have to be analyzed:
When validating purity, assay and release methods, we define the required scope of validation in close consultation with you. With this specification we check the method specifically for the impact of critical parameters (risk assessment).
If we carry out controlled degradation studies (concerning purity methods), special consideration is given to factors such as light, heat, oxidative, acidic and alkaline stress. Following the risk assessment, we determine the acceptance criteria and record them in the validation plan. Of course, we also carry out validations of established methods according to customer-specific validation plans!