Part No: P092Issued year: 2014File size: 0.36mbFile type: pdf
The fermentation process associated with the manufacture of food grade enzyme powders was recently determined to support the colonization of bacteria. To control this issue, manufactures following different international regulatory procedures have found the addition of familiar antibiotic compounds to manufacturing processes beneficial. This becomes an issue of public health as the concentration of antibiotic residues in food grade materials promotes unknown exposure to the global community. Continued interest in the biomonitoring of these compounds have inspired a number of method development strategies; however, classic methods are labor intensive and require multi-step time consuming efforts. The FDA has recently mandated a method for the determination of chloramphenicol in shellfish. This study evaluates the feasibility of method modifications to incorporate enzyme powder matrices into this method. Linearity was determined over a range of 0.1 – 5 ng/mL (r^2 > 0.990). Relative recovery was determined >80%. The typical repeatability (%RSD) for n=7 replicates <20%. Strategies to control solids prior to SPE load will be presented as they were determined critical in method performance. Method robustness was determined by evaluating multiple lots and multiple variants of enzyme powder origin. The key variable is the nature of the excipients as high level sugars of different sources need to be controlled to minimize the ESI suppression.