Validation of high-performance thin-layer chromatographic methods for the identification of botanicals in a cGMP environment.

@article{Reich2008ValidationOH,
  title={Validation of high-performance thin-layer chromatographic methods for the identification of botanicals in a cGMP environment.},
  author={Eike Reich and Anne Schibli and Alison DeBatt},
  journal={Journal of AOAC International},
  year={2008},
  volume={91 1},
  pages={13-20}
}
Current Good Manufacturing Practices (cGMP) for botanicals stipulates the use of appropriate methods for identification of raw materials. Due to natural variability, chemical analysis of plant material is a great challenge and requires special approaches. This paper presents a comprehensive proposal to the process of validating qualitative high-performance thin-layer chromatographic (HPTLC) methods, proving that such methods are suitable for the purpose. The steps of the validation process are… CONTINUE READING

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