Talk:Protocols

Introduction

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Sample Preparation

1. Procedure 1 here

Spectrometer Calibrations

1. Procedure 1 here

Spectrometer Validation

1. Procedure 1 here

NMR Method Development

1. Procedure 1 here

NMR Method Validation

1. Procedure 1 here

Analytical Method Validation References: Guidance Documents

1. Analytical Procedures and Methods Validation for Drugs and Biologics - Guidance for Industry. US Food and Drug Administration.
2. <1225> Validation of Compendial Procedures. United States Pharmacopoeia
3. <761> Nuclear Magnetic Resonance Spectroscopy. United States Pharmacopoeia
4. Validation of Analytical Procedures: Text and Methodology Q2(R1). International Conference on Harmonization
5. Guide to NMR Method Development and Validation - Part I: Identification and Quantification; EUROLAB Technical Report No. 01/2014.
6. Guide to NMR Method Development and Validation - Part II: Multivariate Data Analysis; EUROLAB Technical Report No. 01/2015.
7. Validation of Test Methods - General Principles and Concepts. EUROLAB, 1996.
8. JP
9. JIS
10. ASTM