A Multidisciplinary Investigation to Determine the Structure and Source of Dimeric Impurities in AMG 517 Drug Substance
المؤلفون المشاركون
Bostick, Tracy
Silva Elipe, Maria Victoria
Ronk, Michael
Tan, Zhixin Jessica
المصدر
International Journal of Analytical Chemistry
العدد
المجلد 2009، العدد 2009 (31 ديسمبر/كانون الأول 2009)، ص ص. 1-12، 12ص.
الناشر
Hindawi Publishing Corporation
تاريخ النشر
2008-12-17
دولة النشر
مصر
عدد الصفحات
12
التخصصات الرئيسية
الملخص EN
In the initial scale-up batches of the experimental drug substance AMG 517, a pair of unexpected impurities was observed by HPLC.
Analysis of data from initial LC-MS experiments indicated the presence of two dimer-like molecules.
One impurity had an additional sulfur atom incorporated into its structure relative to the other impurity.
Isolation of the impurities was performed, and further structural elucidation experiments were conducted with high-resolution LC-MS and 2D NMR.
The dimeric structures were confirmed, with one of the impurities having an unexpected C-S-C linkage.
Based on the synthetic route of AMG 517, it was unlikely that these impurities were generated during the last two steps of the process.
Stress studies on the enriched impurities were carried out to further confirm the existence of the C-S-C linkage in the benzothiazole portion of AMG 517.
Further investigation revealed that these two dimeric impurities originated from existing impurities in the AMG 517 starting material, N-acetyl benzothiazole.
The characterization of these two dimeric impurities allowed for better quality control of new batches of the N-acetyl benzothiazole starting material.
As a result, subsequent batches of AMG 517 contained no reportable levels of these two impurities
نمط استشهاد جمعية علماء النفس الأمريكية (APA)
Silva Elipe, Maria Victoria& Tan, Zhixin Jessica& Ronk, Michael& Bostick, Tracy. 2008. A Multidisciplinary Investigation to Determine the Structure and Source of Dimeric Impurities in AMG 517 Drug Substance. International Journal of Analytical Chemistry،Vol. 2009, no. 2009, pp.1-12.
https://search.emarefa.net/detail/BIM-497279
نمط استشهاد الجمعية الأمريكية للغات الحديثة (MLA)
Silva Elipe, Maria Victoria…[et al.]. A Multidisciplinary Investigation to Determine the Structure and Source of Dimeric Impurities in AMG 517 Drug Substance. International Journal of Analytical Chemistry No. 2009 (2009), pp.1-12.
https://search.emarefa.net/detail/BIM-497279
نمط استشهاد الجمعية الطبية الأمريكية (AMA)
Silva Elipe, Maria Victoria& Tan, Zhixin Jessica& Ronk, Michael& Bostick, Tracy. A Multidisciplinary Investigation to Determine the Structure and Source of Dimeric Impurities in AMG 517 Drug Substance. International Journal of Analytical Chemistry. 2008. Vol. 2009, no. 2009, pp.1-12.
https://search.emarefa.net/detail/BIM-497279
نوع البيانات
مقالات
لغة النص
الإنجليزية
الملاحظات
Includes bibliographical references
رقم السجل
BIM-497279
قاعدة معامل التأثير والاستشهادات المرجعية العربي "ارسيف Arcif"
أضخم قاعدة بيانات عربية للاستشهادات المرجعية للمجلات العلمية المحكمة الصادرة في العالم العربي
تقوم هذه الخدمة بالتحقق من التشابه أو الانتحال في الأبحاث والمقالات العلمية والأطروحات الجامعية والكتب والأبحاث باللغة العربية، وتحديد درجة التشابه أو أصالة الأعمال البحثية وحماية ملكيتها الفكرية. تعرف اكثر