Chromatographic Method Validation: A Review of Current Practices and Procedures. I. General Concepts and Guidelines
作者:
DennisR. Jenke,
期刊:
Journal of Liquid Chromatography & Related Technologies
(Taylor Available online 1996)
卷期:
Volume 19,
issue 5
页码: 719-736
ISSN:1082-6076
年代: 1996
DOI:10.1080/10826079608005533
出版商: Taylor & Francis Group
数据来源: Taylor
摘要:
Validation of analytical methodologies is widely recognized as an important aspect of the development/utilization of analytical procedures and is widely required in support of product registration applications. Detailed, specific and comprehensive guidelines for the performance of analytical validations are not universally available. In this manuscript, the role and concept of validation is defined, the necessity for validation is established and published guidelines related to appropriate validation parameters are reviewed. The validation of chromatographic methods for pharmaceutical applications is particularly emphasized.
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