Difference between revisions of "Talk:Protocols"
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==Analytical Method Validation References: Guidance Documents== | ==Analytical Method Validation References: Guidance Documents== | ||
| + | # Analytical Procedures and Methods Validation for Drugs and Biologics - Guidance for Industry. US Food and Drug Administration. | ||
# <1225> Validation of Compendial Procedures. United States Pharmacopoeia | # <1225> Validation of Compendial Procedures. United States Pharmacopoeia | ||
# <761> Nuclear Magnetic Resonance Spectroscopy. United States Pharmacopoeia | # <761> Nuclear Magnetic Resonance Spectroscopy. United States Pharmacopoeia | ||
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# Guide to NMR Method Development and Validation - Part I: Identification and Quantification; EUROLAB Technical Report No. 01/2014. | # Guide to NMR Method Development and Validation - Part I: Identification and Quantification; EUROLAB Technical Report No. 01/2014. | ||
# Guide to NMR Method Development and Validation - Part II: Multivariate Data Analysis; EUROLAB Technical Report No. 01/2015. | # Guide to NMR Method Development and Validation - Part II: Multivariate Data Analysis; EUROLAB Technical Report No. 01/2015. | ||
| + | # Validation of Test Methods - General Principles and Concepts. EUROLAB, 1996. | ||
# JP | # JP | ||
# JIS | # JIS | ||
# ASTM | # ASTM | ||
Revision as of 13:59, 7 April 2017
Contents
Introduction
Hello
Sample Preparation
- Procedure 1 here
Spectrometer Calibrations
- Procedure 1 here
Spectrometer Validation
- Procedure 1 here
NMR Method Development
- Procedure 1 here
NMR Method Validation
- Procedure 1 here
Analytical Method Validation References: Guidance Documents
- Analytical Procedures and Methods Validation for Drugs and Biologics - Guidance for Industry. US Food and Drug Administration.
- <1225> Validation of Compendial Procedures. United States Pharmacopoeia
- <761> Nuclear Magnetic Resonance Spectroscopy. United States Pharmacopoeia
- Validation of Analytical Procedures: Text and Methodology Q2(R1). International Conference on Harmonization
- Guide to NMR Method Development and Validation - Part I: Identification and Quantification; EUROLAB Technical Report No. 01/2014.
- Guide to NMR Method Development and Validation - Part II: Multivariate Data Analysis; EUROLAB Technical Report No. 01/2015.
- Validation of Test Methods - General Principles and Concepts. EUROLAB, 1996.
- JP
- JIS
- ASTM
