Difference between revisions of "Talk:Protocols"
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# Analytical Procedures and Methods Validation for Drugs and Biologics - Guidance for Industry. US Food and Drug Administration. | # Analytical Procedures and Methods Validation for Drugs and Biologics - Guidance for Industry. US Food and Drug Administration. | ||
| − | # <1225> Validation of Compendial Procedures. United States | + | # <1225> Validation of Compendial Procedures. United States Pharmacopeia |
| − | # <761> Nuclear Magnetic Resonance Spectroscopy. United States | + | # <761> Nuclear Magnetic Resonance Spectroscopy. United States Pharmacopeia |
# Validation of Analytical Procedures: Text and Methodology Q2(R1). International Conference on Harmonization | # 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 I: Identification and Quantification; EUROLAB Technical Report No. 01/2014. | ||
Revision as of 14:07, 7 April 2017
Contents
Introduction
The purpose of this page is to collect and share protocols, based on best practices, for a variety of NMR-related activities.
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 Pharmacopeia
- <761> Nuclear Magnetic Resonance Spectroscopy. United States Pharmacopeia
- 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
