Difference between revisions of "Talk:Protocols"

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(Created page with "==Introduction== Hello ==Sample Preparation== # Procedure 1 here ==Spectrometer Calibrations== # Procedure 1 here ==Spectrometer Validation== # Procedure 1 here ==NMR Method D...")
 
(References to Official Documents)
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==NMR Method Validation==
 
==NMR Method Validation==
 
# Procedure 1 here
 
# Procedure 1 here
==References to Official Documents==
+
==Analytical Method Validation References: Guidance Documents==
  
# USP 1225
+
# <1225> Validation of Compendial Procedures. United States Pharmacopoeia
# USP 761
+
# <761> Nuclear Magnetic Resonance Spectroscopy. United States Pharmacopoeia
# Eurolab
+
# 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.
 
# JP
 
# JP
 
# JIS
 
# JIS
 
# ASTM
 
# ASTM

Revision as of 13:53, 7 April 2017

Introduction

Hello

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. <1225> Validation of Compendial Procedures. United States Pharmacopoeia
  2. <761> Nuclear Magnetic Resonance Spectroscopy. United States Pharmacopoeia
  3. Validation of Analytical Procedures: Text and Methodology Q2(R1). International Conference on Harmonization
  4. Guide to NMR Method Development and Validation - Part I: Identification and Quantification; EUROLAB Technical Report No. 01/2014.
  5. Guide to NMR Method Development and Validation - Part II: Multivariate Data Analysis; EUROLAB Technical Report No. 01/2015.
  6. JP
  7. JIS
  8. ASTM