کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
1224042 967907 2008 7 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Evaluation of the European Pharmacopoeia method for control of residual solvents in some antibiotics
موضوعات مرتبط
مهندسی و علوم پایه شیمی شیمی آنالیزی یا شیمی تجزیه
پیش نمایش صفحه اول مقاله
Evaluation of the European Pharmacopoeia method for control of residual solvents in some antibiotics
چکیده انگلیسی

Residual solvents (RS) are volatile organic chemicals that are used or produced during the manufacturing process of drug substances or excipients. The European Pharmacopoeia (Ph. Eur.) limits the amount of RS in pharmaceuticals, considering the International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use guidelines for RS. According to the Ph. Eur. general method, water insoluble samples may be analyzed using DMF as dilution solvent at high equilibration temperatures such as 105 °C. This could be problematic in the case of antibiotics, many of which are water insoluble and temperature sensitive. Moreover, antibiotics are complex in nature and beside RS, one can expect several other volatile impurity peaks in the chromatogram. In this study, the Ph. Eur. method for RS analysis was evaluated for selected groups of antibiotics. An alternative dilution medium was proposed (DMSO–water), which offers optimum sensitivity while working at lower equilibration temperatures such as 80 °C. The optimized method was investigated for precision, accuracy, linearity and detection limits.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volume 48, Issue 1, 10 September 2008, Pages 113–119
نویسندگان
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