Quality Specification And Drug Residue Test Method Study On Linco-Spectin Soluble Powder

With the improvement of people’s living quantity,the concern for veterinary antibiotics is also increasing,more and more people pay attention to food safety.Veterinary antibiotics are a kind of chemicalmedicine,the kinds of drugs are not easy to break down.Long-term large-scale use,will cause accumulation,resulting in pathogens produce drug resistance,and will residue in livestock and poultry,affecting the quality of their products,such as meat,eggs and milk.The further impact will affect human health through the food chain.However,the global restrictions on the use of antibiotics is rigorously,antibiotics is not absolutely can not be used,but to use with the support of scientific experimental data,approved by the state administrative departments,and used in accordance with the product manual exactly.The restriction by European and American countries is reducing use of antibiotics,on the other hand to limit the use of growth-promoting antibiotics.Chinese Ministry of Agriculture asks the company to provide the drug study data sufficiently,when the site apply the new certification or renewal for drug product.Otherwise,they will not issue the new certification.Linco-Spectin soluble powder product has been to Europe,UAS and China market for more than 20 years.Each market has the approved specification.In China,China Imported Veterinary Grade Specification Version 1999 was accepted in previous.But from 2015Y,CVM strengthen the management of veterinary product,only the specification on CVP and government standard will be aeectped.However,Linco-Spectin soluble powder is not included in CVP or government standard.As a result,Zoetis Suzhou site must establish the new specification and get approval by CVM before the expire data of the old certification.Then the site can get the new certification and the product can be manufactured and sold in China continuely.The study is conduct the method validation on HPLC,GC and PAD separately,including specifity,precision,robustness,accuracy,linearity and range.So as to select the best method,establish scientific quality standards,formulate reasonable indications,and use LC-MS/MS to establish the drug residues test method to determination of lincomycin and spectinomycin in animals.To ensure that Linco-Spectin soluble powder is scientifical used and to ensure food safety and human health as well.