UV-VIS 분광기기의 성능검증을 위한 밸리데이션 가이드라인의 제정 및 응용

• 영문명: The Proposed Validation Guidelines and Their Application for Performance Verification of UV-VIS Spectrophotometer
• 발행기관: 대한약학회
• 저자명: 김경옥(Jing Yu Jin) 강영구(Young Koo Kang) 이원재(Wonjae Lee)
• 간행물 정보: 『약학회지』제50권 제3호 (2006년), 154~159쪽, 전체 6쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2006.06.30

영문 초록

For the increasing demand for the validation of analytical results, one of the important concerns of the analyst is to be assured that the instrumentation is working to qualified conditions. In this study, we have investigated and compared several validation guidelines of the performance verification of UV-VIS spectrophotometer used in pharmacopoeias of major countries and UV-VIS instrument analytical companies, and we proposed the practically useful validation guidelines of UV-VIS spectrophotometer. Based on our proposed validation guidelines of UV-VIS spectrophotometer, several UV-vis spectrophotometers used in drug manufacturing laboratories were validated for their performances.

키워드

UV-VIS spectrophotometer validation guideline