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CONSIDERATIONS AND PRACTICAL IMPLICATIONS OF THE GUIDE FOR VALIDATION AND ANALYTICAL QUALITY CONTROL OF DRUGS IN FEED AND VETERINARY DRUGS

机译:饲料和兽药药物验证和分析质量控制指南的考虑和实际意义

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摘要

Recently, the Brazilian Ministry of Agriculture, Livestock and Supply (MAPA) published a validation and analytical quality control guide called the a€?Guia de Valida?§?£o e Controle de Qualidade Anal?-tica a€“ F??rmacos em Produtos para Alimenta?§?£o Animal e Medicamentos Veterin??riosa€?, in order to guide officers and accredited laboratories in the validation of analytical methods for the quality control of veterinary medicines, drug contaminants in feed and depletion studies (residues of drugs in biological matrices). The aim of this study was to present a critical evaluation of the concepts and procedures defined in this document. The Guide was applied for the validation of chromatographic methods intended to be used for the quantification of antimicrobial and antiparasitic drugs in veterinary medicines. Methods for the determination of ivermectin, abamectin, sulfadiazine, sulfadimethoxine, sulfaquinoxaline, streptomycin, dihydrostreptomycin and florfenicol were validated using the Guide. Each validation parameter was evaluated and discussed. A total of 55 samples of veterinary drugs were analyzed.
机译:最近,巴西农业部,畜牧业和供应(MAPA)发表了一个验证和分析质量控制指南,称为a€?郭德有vigwa?§?£oe controlle de qualidade肛门? - 托卡€“f ?? rmacos em Produtos para alimenta?§?£动物e药物reioss ruids ?? riiosa€?,为了指导官员和认可的实验室在验证兽医药物质量控制的分析方法中,饲料和耗尽研究中的药物污染物(残留物生物矩阵中的药物)。本研究的目的是展示本文件中定义的概念和程序的关键评估。该指南用于验证用于在兽药中定量抗微生物和抗寄生虫药物的色谱方法的验证。用指导验证了鉴定伊维菌素,阿维菌素,磺胺嗪,磺基甲嘧啶,磺基喹啉,链霉素,二氢喹啉嘧啶和氟苯嘧啶的方法。每个验证参数都被评估并讨论。分析了共有55种兽药样品。

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