Method Development

With the scrutiny placed on analytical method validation, you’ll want a partner with specific expertise like ours

Sound method development and validation is vital to ensuring quality and reliability of test results, and its documentation is needed to demonstrate procedural suitability. CritiTech has assembled a team with extensive analytical method development and validation expertise, with years of pharmaceutical experience and the innovation to solve any analytical challenges that you may be facing.

From a material identification, quantification and purity perspective (UV/Vis, HPLC, and GC) we provide our customers with transfer, verification and validation of USP and non-pharmacopeia method (including specificity, linearity, accuracy, precision, limit of detection, limit of quantization and robustness).  

CritiTech also specializes in development of new methods for API and/or drug product detection, separation and quantification, as well as improvement of early stage methods for faster throughput and/or enhanced separation. For material characterization, we provide our customers with transfer and validation of particle sizing methods, development of new methods employing multiple techniques (including a wide range of dispersion methods and dispersants), state of the art specific surface area/porosity measurement and understanding, and  visualization/confirmation of methods/results through the use of in-house scanning electron microscopy.  Our team offers these services with the same timeliness, attention to detail and Quality oversight that it provides with all of its other drug development and particle engineering services.