Offer extended until 31 July 2026: get a 10% early-bird discount on all events starting on or after 25 August 2026. To the promotion
GMP search engine – look up GMP compliance regulations and news
New HPTLC Chapter Proposed for The International Pharmacopoeia
Recommendation
20/21 January 2027
Ensuring Control of Chromatographs, Integration and Results
On the Road to 30,000 Members
Let us become the World's Leading GMP/GDP Compliance Community in 2026
The World Health Organization (WHO) has published a draft proposal for a new general chapter "1.18 High-Performance Thin-Layer Chromatography" (HPTLC) to be included in The International Pharmacopoeia.
According to the chapter’s introduction, HPTLC is a chromatographic technique "in which variables are controlled within narrow ranges, using a standardized methodology and appropriate equipment, in order to achieve more reproducible results compared to traditional thin-layer chromatography (TLC)."
The chapter includes:
- An introduction to HPTLC principles
- Required equipment and materials
- A step-by-step analytical procedure
- System suitability criteria and documentation standards
- A new reagent specification (saturated MgCl2 solution)
The draft is currently open for public consultation. Comments can be submitted via the WHO PleaseReview™ platform until 09 September 2025.
The proposed chapter is available on the WHO website under “Working documents in public consultation”.
Related GMP News
03.09.2026USP Article: Supporting the Detection of Asbestos in Pharmaceutical Talc
02.09.2026USP Publishes Comments Received on Chapter <320>
26.08.2026New USP Requirements for Asbestos Testing in Pharmaceutical Talc
19.08.2026FDA Warning Letter: Averaging Data to Override OOS Findings
12.08.2026ECA's Analytical Control Group Publishes Detailed Report on OOS Survey
12.08.2026BP Publishes Key Insights on Limits in Chromatographic Tests