HPLC Method Translation – Allowable changes from USP General Chapter <621>
On December 1 2022, the newly harmonized General Chapter <621> (Chromatography) of the United States Pharmacopeia (USP) became official. The British Pharmacopeia (BP), European Pharmacopeia (EP), and Japanese Pharmacopeia (JP) followed suit in January 2023.
Updates to the “System Suitability” subsection titled, “Adjustment of Chromatographic Conditions,” describe allowable adjustments to chromatography conditions to meet system suitability requirements. These allowable changes can also be used to
- modernize monograph methods
- translate to smaller column dimensions / particle sizes
- use superficially porous particles
- translate gradient methods to retain selectivity whilst reducing analysis time
- shorten analysis time
- reduce solvent consumption
These changes are highly attractive for analysts wishing to increase throughput, reduce issues with ‘problematic methods’ and take advantage of more modern column and instrument technology. These changes can also help to reduce the environmental impact of laboratory methods, by reducing solvent and energy consumption, which is an increasingly important consideration.
Critically, the latest revision of General Chapter <621> allows changes to column dimensions and eluent profile for gradient HPLC methods, opening up new possibilities for improvement of a wider range of compendial methods.
Element Laboratory Solutions offer a number of services to assist you with updating monograph methods, whilst remaining in compliance with the guidance of USP General Chapter <621> and the various requirements regarding subsequent method verification. These strategies can also be applied to non-compendial methods.
Watch this webinar to discover;
- The allowable changes to HPLC methods according to USP General Chapter <621>
- How to interpret allowable changes for both isocratic and gradient methods
- Simple calculations for translating gradient HPLC methods, including free calculator tools
- A range of example monograph method translations highlighting advantages and common pitfalls of method translation
- Useful tools for ensuring minimal selectivity changes when switching between HPLC column manufacturer
- Strategies for verification of translated methods to ensure compliance against system suitability criteria and pharmacopeial recommendations
Our technical experts deliver a comprehensive update on the updates to allowable HPLC method changes and a range of relevant examples will be discussed to highlight advantages and pitfalls of HPLC method modernisation.
Free tools to aid method translation will be demonstrated alongside a new column characterisation system that aids switching between HPLC column manufacturers.
If we know your compendial method in advance, we can supply suitable columns to translate the method on-site and demonstrate the updated method live in your laboratory.
Free Method Translation Tool
- Enables translation of monograph methods using the recommended calculations in USP General Chapter <621>
- Translate column dimensions, particle size, injection volume and gradient profile
- Save time, effort and reduce risk of errors in method translation
Equivalent Stationary Phase Selection Report
Some older HPLC column stationary phases used in compendial methods aren’t available in modern column geometry, particle size or morphology. To reduce the risk associated with the switch to an alternative manufacturers phase of the same compendial classification (L1, L8 etc.), we provide you with an analysis of the original and proposed stationary phase.
From a database of over 600 phases, our model (developed in 2021) is an updated version of the Hydrophobic Subtraction Model developed in 2004 by Snyder, Kirkland and Dolan et. al. and shows similarity and differences between phases using test probes of different chemical characteristics.
Method Translation Laboratory Services
A full method translation and pre-verification service is available, should you wish us to perform the method translation for you, via our analytical development laboratory in Cambridge UK.
Working closely with you to define your method requirements, appropriate system suitability tests and any further verification testing, we can provide updated methods which are faster, greener and equally or more robust than the original compendial method.