Beyond the Routine: Diverse Problems Solved

The advantage of Ricerca's broad spectrum of available analytical techniques can be seen in the widely varied problems we have tackled and solved for several biopharmaceutical clients. Beyond the routine CMC preclinical analytical development projects involving method development, quantitation and structure identification work, we have been able to solve diverse out-of-spec and impurity problems with drug substance preparations and formulations.

Projects have been as varied as finding that bioavailability variation was caused by a previously unidentified chiral isomer, to determining the composition of particulate matter in a parenteral drug product by EDS/SEM and FTIR to help the client determine the source of an impurity.

Another example among many is our tracing the cause of an out-of-spec quality parameter to a previously undetermined polymorph by examining the solid substance with X-ray diffraction.