Case Study: Residual Solvents per USP method [467]

PROBLEM: Residual Solvents per USP method <467>

SOLUTION: Developed and Validated a Modified <467> Method for the Client's Product

TECHNIQUES: GC-FID

A medical device company with a drug-delivery patch needed a method for residual solvents. Testing under USP method <467> was desired, but the test article was not applicable for the preparation conditions listed in the method.

SOLUTION & RESULTS:
Impact Analytical developed and validated a method for residual solvents under cGMP.  USP method <467> was modified to accommodate the test material, but the core of the method was retained. A headspace GC-FID method for residual solvents was developed. The method achieved a detection limit of 0.1 ppm, and was linear throughout a range from 1 ppm (LOQ) to 1000 ppm. Recoveries were between 97 and 102%, and precision was 5% RSD for injection of standards at the specification level of the test material. The resulting submission to the FDA was accepted without need for further explanation or response.

Small Contact Banner 340 x 90