کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
2486657 | 1114389 | 2011 | 32 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Identification of Pharmaceutical Impurities in Formulated Dosage Forms
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کلمات کلیدی
موضوعات مرتبط
علوم پزشکی و سلامت
داروسازی، سم شناسی و علوم دارویی
اکتشاف دارویی
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چکیده انگلیسی
Structure elucidation of pharmaceutical impurities is an important part of the drug product development process. Impurities can have unwanted pharmacological or toxicological effects that seriously impact product quality and patient safety. This review focuses on current analytical strategies for chemical and structural identification of pharmaceutical impurities. Potential sources and mechanisms of impurity formation are discussed for both drug substance and drug product applications. The utility of liquid chromatography-mass spectrometry (LC/MS) for providing structure-rich information is highlighted throughout this review. Other hyphenated analytical techniques including LC/nuclear magnetic resonance, gas chromatography/MS, and size-exclusion chromatography/chemiluminescent nitrogen detectors are also discussed, as LC/MS alone sometimes cannot reveal or confirm the final structures as required during dosage form development.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 100, Issue 4, April 2011, Pages 1228-1259
Journal: Journal of Pharmaceutical Sciences - Volume 100, Issue 4, April 2011, Pages 1228-1259
نویسندگان
Changkang Pan, Frances Liu, Michael Motto,