Method Validation Approaches for Pharmaceutical Assessments – Highlights with High Performance Thin Layer Chromatographic (HPTLC) Techniques

Author:

Jenkins David,Diallo Cherif,Bethea Ed,Kaale Eliangiringa,Layloff Thomas

Publisher

InTech

Reference51 articles.

1. USP 40/NF 35, United States Pharmacopeia. 40th ed., National Formulary. 35th ed. Rockville, MD: The United States Pharmacopeia Convention; United Book Press, Inc.; 2017

2. International Conference for Harmonization (ICH) [Internet]. 2017. Available from: http://www.ich.org/home.html [Accessed: Sep, 25 2017]

3. USP <1225> Validation of Compendial Procedures. In: USP 40/NF 35, United States Pharmacopeia. 40th ed., National Formulary. 35th ed. Rockville, MD: The United States Pharmacopeia Convention; United Book Press, Inc.; 2017

4. Validation of Analytical Procedures: Text and Methodology Q2(R1) [Internet]. 2005. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q2_R1/Step4/Q2_R1__Guideline.pdf [Accessed: Sep, 25 2017]

5. Ferenczi-Fodor A, Vigh Z, Nagy-Turak A. Validation and quality assurance of planar chromatographic procedures in pharmaceutical analysis. Journal - Association of Official Analytical Chemists. 2001;84(4):1265-1276

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