Difference between revisions of "Talk:Protocols"

From validwiki
Jump to: navigation, search
(Analytical Method Validation References: Guidance Documents)
(Spectrometer Calibrations)
Line 5: Line 5:
 
# Procedure 1 here
 
# Procedure 1 here
 
==Spectrometer Calibrations==
 
==Spectrometer Calibrations==
# Procedure 1 here
+
# Lineshape
 +
# Sensitivity
 +
# 90<sup>o</sup> Pulse width
 +
 
 
==Spectrometer Validation==
 
==Spectrometer Validation==
 
# Procedure 1 here
 
# Procedure 1 here

Revision as of 10:40, 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

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