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
You will benefit from our skills and extensive experience with method development and method validation Contact us today!
SYNLAB Umweltinstitut GmbH
pharma institute Aachen
Auf der Hüls 183
+49 (0) 241 475 736 0