To ensure the reliability of analytical results for E&L studies and structure elucidation, for example, individual analytical methods must be fully validated to identify and quantify the substances. Usually there are very small quantities of the marker substances. Hence, the development and validation of qualitative and robust methods necessitates experience and state-of-the-art equipment.
Our clients benefit from our more than 10-years of analytical experience using cutting edge analytical tools. We offer method development and validation for solid, semi-solid and liquid dosage forms. After a qualitative method is developed the latter will be extensively validated according to the validation plan and the ICH guidelines (ICH Q2 (R1)). If necessary, we also validate existing methods based on customer-specific validation plans. Furthermore, we offer our clients method transfer in the routine laboratory, including the creation of transfer protocols and reports.
Method development summary:
- identity, content, purity, and robustness
- customized method development – no intellectual property (IP)
Method validation summary:
- in accordance with ICH Q2(R1) or based on client demands and equipment (assay and identification)
- accuracy, precision, specificity, LOD/LOQ, linearity and range
- limit test and quantification
- validation protocol and report
- method Transfer