Chromatographic Method Validation: A Review of Current Practices and Procedures. Part II. Guidelines for Primary Validation Parameters
Тип публикации: Journal Article
Дата публикации: 1998-01-01
scimago Q3
wos Q4
white level БС2
SJR: 0.274
CiteScore: 3.2
Impact factor: 1.3
ISSN: 10739149, 15256030
General Chemical Engineering
Instrumentation
General Environmental Science
Краткое описание
Abstract Validation of analytical methodologies is an important aspect of their development/utilization and is widely required in support of product registration applications. In this manuscript, definitions, procedures and acceptance criteria which appear in the pharmaceutical literature are summarized for the more commonly encountered validation parameters. Parameters examined include accuracy, precision, specificity, linearity and sensitivity limits. †Previously published in J. Liq. Chrom. & Rel. Technol., 19(12), 1873-1891 (1996).
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Jenke D. R. Chromatographic Method Validation: A Review of Current Practices and Procedures. Part II. Guidelines for Primary Validation Parameters // Instrumentation Science and Technology. 1998. Vol. 26. No. 1. pp. 1-18.
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Jenke D. R. Chromatographic Method Validation: A Review of Current Practices and Procedures. Part II. Guidelines for Primary Validation Parameters // Instrumentation Science and Technology. 1998. Vol. 26. No. 1. pp. 1-18.
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TY - JOUR
DO - 10.1080/10739149808002086
UR - https://doi.org/10.1080/10739149808002086
TI - Chromatographic Method Validation: A Review of Current Practices and Procedures. Part II. Guidelines for Primary Validation Parameters
T2 - Instrumentation Science and Technology
AU - Jenke, Dennis R
PY - 1998
DA - 1998/01/01
PB - Taylor & Francis
SP - 1-18
IS - 1
VL - 26
SN - 1073-9149
SN - 1525-6030
ER -
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@article{1998_Jenke,
author = {Dennis R Jenke},
title = {Chromatographic Method Validation: A Review of Current Practices and Procedures. Part II. Guidelines for Primary Validation Parameters},
journal = {Instrumentation Science and Technology},
year = {1998},
volume = {26},
publisher = {Taylor & Francis},
month = {jan},
url = {https://doi.org/10.1080/10739149808002086},
number = {1},
pages = {1--18},
doi = {10.1080/10739149808002086}
}
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MLA
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Jenke, Dennis R.. “Chromatographic Method Validation: A Review of Current Practices and Procedures. Part II. Guidelines for Primary Validation Parameters.” Instrumentation Science and Technology, vol. 26, no. 1, Jan. 1998, pp. 1-18. https://doi.org/10.1080/10739149808002086.
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