دورية أكاديمية
Validation of Mometasone furoate and CIP100 Residue Analysis Methods After Cleaning of Production Equipment in the 'XYZ' Pharmaceutical Industry
| العنوان: | Validation of Mometasone furoate and CIP100 Residue Analysis Methods After Cleaning of Production Equipment in the 'XYZ' Pharmaceutical Industry |
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| المؤلفون: | Amaandika Galih Arintowibowo, Ririn Sumiyani, Kusuma Hendrajaya |
| المصدر: | Jurnal Kimia Sains dan Aplikasi, Vol 22, Iss 4, Pp 150-156 (2019) |
| بيانات النشر: | Chemistry Department, Faculty of Sciences and Mathematics, Diponegoro University, 2019. |
| سنة النشر: | 2019 |
| المجموعة: | LCC:Chemistry |
| مصطلحات موضوعية: | mometasone furoate, cleaning validation, surfaces of production equipment, analysis of total organic carbon (toc), hplc, Chemistry, QD1-999 |
| الوصف: | In this study, the HPLC and Total Organic Carbon (TOC) analysis methods have been developed and validated for the determination of the amount of Mometasone furoate and CIP100 residues on the surface of production equipment and to confirm the efficiency of the cleaning procedure. Mometasone furoate and CIP100 have been chosen based on the worst case assessment approach. The limit of mometasone furoate contamination that has been determined is 100 ug/swab and the specified limit of CIP100 contamination is 100 ug/swab which should not be exceeded during sequential cleaning of the equipment. Mometasone furoate shows good linearity in the range 0.1-1.0 ppm for the HPLC method and CIP100 2.0-10.0 ppm for TOC Analysis. The percentage of recovery from stainless steel plates using swab sampling techniques was found in the limits of 95.12% and 99.93% respectively in the HPLC and TOC methods. Both methods are simple, inexpensive, short analysis time and high sensitivity for quantitative determination of Mometasone furoate and CIP100 on the surface of manufacturing equipment well below the contamination limit. The validated method meets the requirements for demonstration of the validation of residual cleaning of mometasone furoate and CIP100 on the surface of production equipment |
| نوع الوثيقة: | article |
| وصف الملف: | electronic resource |
| اللغة: | English Indonesian |
| تدمد: | 1410-8917 2597-9914 |
| العلاقة: | https://ejournal.undip.ac.id/index.php/ksa/article/view/23083Test; https://doaj.org/toc/1410-8917Test; https://doaj.org/toc/2597-9914Test |
| DOI: | 10.14710/jksa.22.4.150-156 |
| الوصول الحر: | https://doaj.org/article/a9c0f27dc42643478a7759969fb58db3Test |
| رقم الانضمام: | edsdoj.9c0f27dc42643478a7759969fb58db3 |
| قاعدة البيانات: | Directory of Open Access Journals |
| تدمد: | 14108917 25979914 |
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| DOI: | 10.14710/jksa.22.4.150-156 |