Uncertainty Estimation for Purity Determination of Adalimumab Using Size Exclusion High-Performance Liquid Chromatography (SE-HPLC)

سال انتشار: 1403
نوع سند: مقاله کنفرانسی
زبان: انگلیسی
مشاهده: 93

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شناسه ملی سند علمی:

NICEC22_378

تاریخ نمایه سازی: 7 مرداد 1403

چکیده مقاله:

Estimation uncertainty emerges as a potent tool, significantly enhancing the integrity of qualityassurance and the overall excellence of analytical work. In this research, the General Uncertainty Management(GUM) framework is applied to scrutinize the standard uncertainty of HPLC for Adalimumab. The calculateduncertainties (۹۹.۴۵ ± ۰.۱۴%) have been obtained

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نویسندگان

Vahid Farzaneh

CinnaGen Medical Biotechnology Research Center, Alborz University of Medical Sciences, Karaj, Iran.b CinnaGen Research and Production Co, Alborz, Iran.

Hiva Tehrani

CinnaGen Medical Biotechnology Research Center, Alborz University of Medical Sciences, Karaj, Iran.b CinnaGen Research and Production Co, Alborz, Iran.

Maryam Davoudi

CinnaGen Medical Biotechnology Research Center, Alborz University of Medical Sciences, Karaj, Iran.b CinnaGen Research and Production Co, Alborz, Iran.

Zahra Azarniad

CinnaGen Medical Biotechnology Research Center, Alborz University of Medical Sciences, Karaj, Iran.b CinnaGen Research and Production Co, Alborz, Iran.