Development of a Rapid Analytical Method on UV Spectrophotometer for Analysis of Trace Level APIs Telmisartan in Cleaning Validation Sample

Seema Jamle, Archana Tiwari, Shikha Nagle, P.K. Dubey
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Abstract

Since the 1990’s, cleaning validations have gained a lot of interest within pharmaceutical and bio-pharmaceutical companies. In 1988, the FDA experienced its first major incident with cross contamination traceable to inadequate cleaning and cleaning validation. The finished drug product, Cholestyramine Resin USP, was recalled due to contamination with low levels of intermediates and degradants from the production of agricultural pesticides. The cross-contamination was believed to have come from the use of drums in the production of the active pharmaceutical ingredient (API). These drums had previously been used to store solvents for the manufacture of agricultural pesticides at another plant. Extra pure methanol procured from Chempura Enterprises Indore of make Merck and Analytical Grade water procured from the SK Traders Indore M.P. Reference materials, Telmisartan from Axiom Analytical Services Indore M.P. HPLC grade methanol (MeOH), HPLC Grade Water were purchased from Chempura Enterprises Indore M.P.. All chemicals were used as received, without any further purification. In recent years, increased emphasis has been placed in pharmaceutical companies for implementing robust validated cleaning procedures. The cleaning procedure is one of the most important tasks to avoid contamination and cross- contamination of APIs in pharmaceutical products manufactured on the same equipment trains. The cleaning procedures must be supported byappropriate analytical methods and related sampling methodologies.
开发紫外分光光度计快速分析法,用于分析清洁验证样品中的痕量原料药替米沙坦
自 20 世纪 90 年代以来,清洁验证在制药和生物制药公司中获得了广泛关注。1988 年,美国食品和药物管理局(FDA)经历了第一起可追溯到清洁和清洁验证不足造成交叉污染的重大事故。成品药 Cholestyramine Resin USP 因受到来自农用杀虫剂生产的低水平中间体和降解剂的污染而被召回。据信,交叉污染是由于在生产活性药物成分 (API) 的过程中使用了圆桶造成的。这些桶以前曾在另一家工厂用于储存生产农用杀虫剂的溶剂。特纯甲醇购自默克公司在印多尔的 Chempura Enterprises,分析级水购自印多尔的 SK Traders。所有化学品均按原样使用,未作任何进一步纯化。近年来,制药公司越来越重视实施可靠有效的清洗程序。清洗程序是最重要的任务之一,可避免在同一设备列车上生产的医药产品中的原料药受到污染和交叉污染。清洗程序必须辅以适当的分析方法和相关的取样方法。
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