Method Development/Validation
R. D. Laboratories, Inc. provides both method development and validation services. Typically, we are asked to develop a method for the analysis of an active drug substance in a finished product. Most often a HPLC procedure is preferred since separation from other components is possible as well as examination by a Photo Diode Array Detector (DAD) to establish peak purity. Also, modern HPLC instrumentation lends itself to automation, high sample volumes and accuracy at low levels. However, in some instances, other types of instrumentation are required for validation by nature of the analyte, i.e., mineral supplements. GC is another useful technique used occasionally for API but usually for residual solvent analysis.
ICH (International Conference on Harmonization), EP (European Pharmacopoeia) and USP (United States Pharmacopeia) offer guidelines for validation. They specify typical analytical characteristics of data elements. Depending on the test method and purpose (assay, impurity, degradation product, limit test, etc.), a validation may include accuracy, precision, specificity, detection limit, linearity, range and robustness. R. D. Laboratories, Inc. has extensive experience with method development and validation. We are ready to discuss your requirements and protocols.
