Analytical Literature

We have provided several links and literature references purely for information purposes only. These websites are neither maintained nor endorsed by PrimeSyn Lab Inc. PrimeSyn Lab is not affiliated to any one of these. If you incurr any problem with the website content or usibility, please contact the individual website owner directly. Please write an email to us if you would desire any additional links to be added.

Method Validation Websites

• US Food & Drug Administration
• US Center for Drug Evaluation & Research
• United States Pharmacopeia
• International Conference on Harmonisation
• The Scientific Association Dedicated to Analytical Excellence

Google Scholar Search Engine
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Text Books

Analytical Chemistry in a GMP Environment: A Practical Guide, by James M. Miller and Jonathan B. Crowther, 2000. Publisher: Wiley-Interscience.

Practical HPLC Method Development, 2nd Edition. by Lloyd. R. Snyder, Joseph J. Kirkland, and Joseph L. Glajch, 1997. Publisher: Wiley-Interscience.

HPLC Columns, Theory, Technology, and Practice. by Uwe D. Neue, 1997. Publisher: Wiley-VCH

Troubleshooting HPLC Systems: A Bench Manual. by Paul C. Sadek, 1999. Publisher: Wiley-Interscience

HPLC Solvent Guide. by Paul C. Sadek, 2002. Publisher: John Wiley & Sons.


References

1. International Conference on Harmonization, Guidance on Validation of Analytical Procedures: Methodology, Federal register, 1996, 61, 59-62.
   
   
2. J. M. Green, A Practical Guide to Analytical Method Validation, Anal. Chem., 1996, 68, 305A-309A.
   
   
3. "Guidance for Industry: Analytical Procedures and Methods Validation," FDA (August 2000).
   
   
4. "Guidance for Industry: Bioanalytical Method Validation," FDA (May 2001).
   
   
5. "Guideline for Industry: Text on Validation of Analytical Procedures," ICH-Q2A (March 1995).
   
   
6. "Guidance for Industry: Q2B Validation of Analytical Procedures: Methodology," ICH (November 1996).
   
   
7. O Doblhoff-Dier and R Bliem, “Quality Control and Assurance from the Development to the Production of Biopharmaceuticals”, Trends Biotech., 17 (1999), pp. 266–270.
   
   
8. The United States Pharmacopeia, USP 28, Rockville, Maryland (2005).
   
   
9. R. Aebersold and M. Mann, Nature 422, 198-207 (2003). article on peptide separation.
   
   
10. G A Shabir, “Validation of High Performance Liquid Chromatography Methods for Pharmaceutical Analysis, Understanding the Differences and Similarities Between Validation Requirements of the US Food and Drug Administration, the US Pharmacopeia and the International Conference on Harmonisation”, J. Chromatogr., A 987 (2003), pp. 57–66.
    
    
11. M Bakshi and S Singh, “Development of Validated Stability Indicating Assay Method – Critical Review”, J. Pharm. Biomed. Anal., 28 (2002), pp. 1,011–1,040.
    
    
12. EURACHEM Guidance Document No. 1/WELAC Guidance Document No. WGD 2: Accreditation for chemical laboratories: Guidance on the interpretation of the EN 45000 series of standards and ISO/IEC Guide 25,1993. Available from the EURACHEM Secretariat, PO Box 46, Teddington, Middlesex, TW11 ONH, UK,
    
    
13. International Conference on Harmonization (ICH) of Technical Requirements for the Registration of Pharmaceuticals for Human Use, Validation of analytical procedures, ICH-Q2A, Geneva 1995.
    
    
14. International Conference on Harmonization (ICH) of Technical Requirements for the Registration of Pharmaceuticals for Human Use, Validation of analytical procedures: Methodology, ICH-Q2B, Geneva 1996.
    
    
15. US EPA, Guidance for methods development and methods validation for the Resource Conservation and Recovery Act (RCRA) Program, Washington, 1995.
    
    
16. US FDA Technical Review Guide: Validation of Chromatographic Methods, Center for Drug Evaluation and Research (CDER), Rockville, MD, 1993.
    
    
17. P van Zoonen, et al., “Some Practical Examples of Method Validation in the Analytical Laboratory”, Trends Anal. Chem., 18 (1999), pp. 584–593.
    
    
18. D G Chapman, “The Principles and Applications of Quality Assurance”, Pharmaceutical Practice, A J Winfield and R M E Richards (eds), Third Edition, London: Churchill Livingstone, 2004, pp. 66–76.
    
    
19. M J Benoliel, “Step-by-step Implementation of a Quality System in the Laboratory”, Trends Anal. Chem., 18 (1999), pp. 632–638.
    
    
20. US FDA, General principles of validation, Rockville, MD, Center for Drug Evaluation and Research (CDER), May 1987.
    
    
21. US FDA, Guidelines for submitting samples and analytical data for method validation, Rockville, MD, Center for Drugs and Biologics Department of Health and Human Services , Feb. 1987
    
    
22. General Chapter <1225>, Validation of compendial methods, United States Pharmacopeia XXIII, National Formulary, XVIII, Rockville, MD, The United States Pharmacopeial Convention, Inc, 1995, 1710–1612
    
    
23. Szepesi, M. Gazdag and K. Mihalyfi, Selection of HPLC methods in pharmaceutical analysis -III method validation, J.Chromatogr. 464, 265-278
    
    
24. P. Shah et al., Analytical methods validation: Bioavailability, bioequivalence and pharmacokinetic studies, Eur. J. Drug Metabolism and Pharmacokinetics, 16(4), 249-255, 1989 (1991)
    
    
25. G.C. Hokanson, A life cycle approach to the validation of analytical methods during pharmaceutical product development, part I: The initial validation process, Pharm.Tech., Sept. 1994, 118-130
    
    
26. G.C. Hokanson, A life cycle approach to the validation of analytical methods during pharmaceutical product development, part II: Changes and the need for additional validation, Pharm.Tech., Oct. 1994, 92-100.
    
    
27. J.M.Green, A practical guide to analytical method validation, Anal.Chem. News & Features, May 1, 1996, 305A/309A
28. B. Renger, H.Jehle, M.Fischer and w. Funk, Validation of analytical procedures in pharmaceutical analytical
29. Chemistry: HPTLC assay of theophylline in an effervescent tablet, J.Planar Chrom., 8, July/Aug 1995, 269-278
30. Wegscheider, Validation of analytical methods, in "Accreditation and quality assurance in analytical chemistry", edited by H. Guenzler, Springer Verlag, Berlin 1996
    
31. AOAC Peer Verified methods Program, Manual on policies and procedures, Arlington, VA, Nov 1993
    
    
32. J.Vessman, Selectivity or specificity ? Validation of analytical methods from the perspective of an analytical chemist in the pharmaceutical industry, J.Pharm&Biomed Analysis, 14 (1996) 867/869
    
    
33. Huber, L. "Validation of computerized analytical systems, Part 3: Installation and operational qualification"; LC-GC Magazine 1996, 14(9), 806-812
34. L. Huber, Validation of Computerized Analytical Systems, Interpharm, Buffalo Grove, IL, 1995
    
    
35. Huber, Applications of diode-array detection in HPLC, Waldbronn, Germany, Agilent Technologies, 1989, publ. number 12-5953-2330
    
    
36. D. Marr, P. Horvath, B. J. Clark, A. F. Fell, Assessment of peak homogeneity in HPLC by computer-aided photodiode-array detection, Anal. Proceed., 23, 254-257, 1986 
    
    
37. Huber and S. George, Diode-array detection in high-performance liquid chromatography, New York, Marcel Dekker, ISBN 0-8247-4, 1993