Difference between revisions of "Talk:Protocols"

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(Spectrometer Calibrations)
 
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==Introduction==
 
==Introduction==
Hello
+
The purpose of this page is to collect and share protocols, based on best practices, for a variety of NMR-related activities.
 +
 
 
==Sample Preparation==
 
==Sample Preparation==
 
# Procedure 1 here
 
# Procedure 1 here
 
==Spectrometer Calibrations==
 
==Spectrometer Calibrations==
# Procedure 1 here
+
# Lineshape
 +
# Sensitivity
 +
# 90<sup>o</sup> Pulse Width
 +
# Decoupling
 +
 
 
==Spectrometer Validation==
 
==Spectrometer Validation==
 
# Procedure 1 here
 
# Procedure 1 here
Line 11: Line 16:
 
==NMR Method Validation==
 
==NMR Method Validation==
 
# Procedure 1 here
 
# Procedure 1 here
==References to Official Documents==
+
==Analytical Method Validation References: Guidance Documents==
  
# USP 1225
+
# Analytical Procedures and Methods Validation for Drugs and Biologics - Guidance for Industry. US Food and Drug Administration.
# USP 761
+
# <1225> Validation of Compendial Procedures. United States Pharmacopeia
# Eurolab
+
# <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
 
# JP
 
# JIS
 
# JIS
 
# ASTM
 
# ASTM

Latest revision as of 10:46, 27 April 2017

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
  4. Decoupling

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