Talk:Protocols

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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

  1. Procedure 1 here

Spectrometer Calibrations

  1. Lineshape
  2. Sensitivity
  3. 90o Pulse width

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 Pharmacopeia
  3. <761> Nuclear Magnetic Resonance Spectroscopy. United States Pharmacopeia
  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
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