26.08.2015

USP features two new chapters on HPTLC


The United States Pharmacopoeia recently published two important chapters on HPTLC in their First Supplement to USP 38–NF 33.

Chapter 1064 - Identification of Articles of Botanical Origin by High-Performance Thin-Layer Chromatography Procedure (pdf)

Chapter 203 - High-Performance Thin-Layer ChromatographyProcedure for Identification of Articles of Botanical Origin (pdf)

More information from USP:

Chapter 1064 Identification of Articles of Botanical Origin by High-Performance Thin-Layer Chromatography Procedure (GENERAL INFORMATION)

Because there is no existing USP general information chapter on this topic, a new one is proposed. HPTLC is widely used for botanical identification. Variability of the chromatographic conditions has the potential to significantly impact the
results. This informational general chapter describes, with illustrations, the need to control the relevant variables in order to obtain reproducible results.

Chapter 203 HPTLC Procedure for Identification of Articles of Botanical Origin (CHEMICAL TESTS)

This chapter describes a standardized procedure for use in a USP Identification test that relies on the technique of HPTLC. It is applicable to the identification of articles of botanical origin in USP's compendia that serve as a drug substance or drug product, or as an ingredient or a dietary supplement. Careful control of the variables for the HPTLC technique is briefly described with references to more detailed information provided in equipment manuals. Reproducibility of the results allows comparison of closely related botanical materials that are not official ingredients. The analytical technique uses high-performance plates, appropriate equipment to control variables, and a system suitability test for purposes of performance qualification.


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