Difference between revisions of "Talk:Protocols"

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(References to Official Documents)
(Analytical Method Validation References: Guidance Documents)
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==Analytical Method Validation References: Guidance Documents==
 
==Analytical Method Validation References: Guidance Documents==
  
 +
# Analytical Procedures and Methods Validation for Drugs and Biologics - Guidance for Industry. US Food and Drug Administration.
 
# <1225> Validation of Compendial Procedures. United States Pharmacopoeia
 
# <1225> Validation of Compendial Procedures. United States Pharmacopoeia
 
# <761> Nuclear Magnetic Resonance Spectroscopy. United States Pharmacopoeia
 
# <761> Nuclear Magnetic Resonance Spectroscopy. United States Pharmacopoeia
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# 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 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.
 
# 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

Revision as of 13:59, 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. 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