Page 44 - BR20828_E Accucore 0713S

Column Parameter Allowed Change
Column length ± 70%
Column internal diameter ± 25%
Particle size Reduction of up to 50%; no increase
Method Parameter Allowed Change
Flow rate ± 50%
Injection volume System suitability testing (SST) criteria must be met
Column temperature ± 10%
Mobile phase pH ± 0.2
UV wavelength No changes outside manufacturer specifications
Concentration of salts in buffer ± 10%
Composition of mobile phase Minor component adjustment ± 30% or ± 10% abso-
lute, whichever is smaller
Adjusting Conventional HPLC Methods
For users of conventional HPLC methods working in regulated environments there may be
regulatory issues to consider when changing columns in order to realise the improvements
offered by newer technologies. For example USP (United States Pharmacopeia) General
Chapter <621> Chromatography-System Suitability describes the maximum adjustments
that can be made to an analysis so that a method still fulfils the requirements of the system
suitability test.
Transferring a method from a column packed with a 5 µm fully porous material to an
Accucore XL 4 µm HPLC column requires no changes to method parameters and involves
only a 20% reduction in particle size–thus meeting the above requirements.