Arintowibowo, Amaandika galih (2019) Validasi Metode Analisis Residu Mometasonefuroate dan CIPioo Setelah Proses Pembersihan Peralatan Produksi di Industri Farmasi “XYZ”. Validasi Metode Analisis Residu Mometasonefuroate dan CIPioo Setelah Proses Pembersihan Peralatan Produksi di Industri Farmasi “XYZ”, 22 (4). pp. 150-156. ISSN 1410-8917
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Abstract
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 CIPioo residues on the surface of production equipment and to confirm the efficiency of the cleaning procedure. Mometasone furoate and CIPioo have been chosen based on the worst case assessment approach. The limit of mometasone furoate contamination that has been determined is100 ug/swab and the specified limit of CIPioo 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 CIPioo 2.0-10.0 ppm for TOC Analysis. The percentage of recovery from stainlesssteel plates usingswab 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 CIPioo 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 CIPioo on the surface of production equipment
| Item Type: | Article |
|---|---|
| Subjects: | R Medicine > RS Pharmacy and materia medica |
| Divisions: | Postgraduate Programs > Master Program in Clinical Pharmacy |
| Depositing User: | Amaandika Galih Arintowibowo |
| Date Deposited: | 31 Jul 2019 02:39 |
| Last Modified: | 24 Mar 2021 16:07 |
| URI: | http://repository.ubaya.ac.id/id/eprint/35239 |
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