Development of liquid chromatography-tandem mass spectrometry method for testing animal injection solutions contaminated with β-lactam antibiotics
Wen-Hua Lin
Abstract
Currently the surveillance system for harmful substances in animal drugs in the domestic market is incomplete. For non-penicillin products, testing is necessary to ensure that there is no contamination of penicillin, hormone, or cephalosporin drugs, in accordance with Article 34 of the Guidelines of Good Manufacturing Practice (GMP) for Veterinary Drug Manufacturers. The U.S. Food and Drug Administration (FDA) requires the detection of penicillin G and ampicillin residues in non-beta-lactam drugs at the level of 0.03 ppm. The measurement of cross-contamination is codified at 21 CFR 211.176 and 436.104, with a minimum detection limit of 0.006 ppm. Because of the high risk of contaminating regular pharmaceuticals in the domestic market, it is necessary to establish multiple inspection technology for the twelve most used beta-lactam antibiotics, using the ultra-high-performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS) method. This method employs positive and negative ions of the electrospray ionization (ESI) which are switched in multiple reaction monitoring (MRM) mode. The linear regression coefficients for the pure solvent calibration curve concentration ranging from 0.5 to 50 ppb were all greater than 0.995, with a limit of detection (LOD) of 0.2 ppb and a limit of quantification (LOQ) of 0.5 ppb. The recovery rate of twelve beta-lactam antibiotics in drug products of injection were found to be within the range of 80 to 101% for concentrations of 0.5 ppb and 2.5 ppb. The specificity check showed no interference signals at the same time point. The relative standard deviation (RSD) of intra-day precision was 1.21 to 5.52, and the RSD of inter-day precision was 1.49 to 7.79. This method could be used for monitoring non-beta-lactam drugs in domestic animal medicines or as a cleanliness analysis method for domestic manufacturers.
Rehabilitation Plan for Ferret Badger and Gem-Faced Civet
Chih-Shuan Sheng
Abstract
AHRI has been keeping ferret badgers and gem-faced civets for the use on rabies related researches, since Taiwan first diagnosed rabies in ferret badger in July, 2013. In considering about animal welfare and to decrease animal sacrifice in our research, instead of euthanasia, a rehabilitation plan was made for the animals when they reach the point for retirement. Four government agencies, including Forestry Bureau, Endemic Species Research Institute, Bureau of Animal and Plant Health Inspection and Quarantine, and Animal Health Research Institute have cooperated in returning the animals back to their habitat.