PharmSky was challenged to detect the three impurities down to trace levels (ppb) for a client interested in the development of oil-based treatments for infantile spasms.
Chloropropanol’s (2-MCPD and 3-MCPD) and glycidol fatty acid ester (GE) are impurities of concern in refined oil products as they can damage DNA and cause cancer if consumed at high levels. Although consumption levels are generally considered safe, there is a higher risk in younger age groups, especially infants.
Published methods include time consuming, complex derivatisation and extraction processes with detection typically limited to ppm. Accessing an advanced Agilent GC-MS/MS system and using internal standards to compensate for losses during the extraction procedure, PharmSky scientists developed a simplified method with quantitation limit down to 10 pbb.
The method was validated to ICH guidelines, achieving a remarkable recovery of 90%. The robust method will enable the client to develop safe products with low levels of the potential carcinogens.
