کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
1223142 967882 2011 7 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Isolation and identification of five impurities of ALB 109564(a) drug substance
موضوعات مرتبط
مهندسی و علوم پایه شیمی شیمی آنالیزی یا شیمی تجزیه
پیش نمایش صفحه اول مقاله
Isolation and identification of five impurities of ALB 109564(a) drug substance
چکیده انگلیسی
Four low-level impurities were detected during the development and scale up of the synthesis of ALB 109564(a). These impurities were isolated and characterized in order to determine how they originated in the drug substance. The information allowed the elimination of one impurity and a significant reduction in the relative abundance of the other three. A fifth impurity was detected in an accelerated stability study sample of the drug substance. The degradant was found to be the free acid resulting from the hydrolysis of the methyl ester within the indoline moiety of ALB 109564(a). The characterization of this impurity allowed for changes in the handling of the drug substance which minimized the formation of the impurity.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volume 55, Issue 2, 15 May 2011, Pages 366-372
نویسندگان
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