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Pharmacopeial Method Support

Our tech team have many years experience working with pharmacopoeial methods. From selecting the correct column, to making modifications within the allowed deviations, to resolving many of the common problems seen with these methods our team can give you all the advice you need.

Any customers following USP, BP or any pharmacopeial methods can now take advantage of this service which shows how they can improve their throughput using new columns and conditions without having to re-validate methods and remaining compliant. Element delivers this via a seminar and then implementation is consultancy based with the client as we transfer the new methods to their labs.

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The pharmacopoeias allow the following modifications to the basic conditions specified in the monograph:


HPLC

Composition of the mobile phase: the amount of the minor solvent component may be adjusted by ± 30 per cent relative
or ± 2 per cent absolute, whichever is the larger. No other component is altered by more than 10 percent absolute.

pH of the aqueous component of the mobile phase: ± 0.2 pH, unless otherwise stated in the monograph, or ± 1.0 pH when neutral substances are to be examined.

Concentration of salts in the buffer component of a mobile phase: ± 10 per cent.

Stationary phase:
Column length: ± 70 per cent,
Column internal diameter: ± 25 per cent,
Particle size: maximal reduction of 50 per cent, no increase permitted.

Flow rate : ± 50 per cent. When in a monograph the retention time of the principle peak is indicated, the flow rate has to be adjusted if the column internal diameter has been changed. No decrease of flow rate is permitted if the monograph uses apparent number of theoretical plates in the qualification section.

Temperature : ± 10 per cent, to a maximum of 60 °C.

Injection volume: may be decreased, provided detection and repeatability of the peak(s) to be determined are satisfactory.

Gradient elution: the configuration of the equipment employed may significantly alter the resolution, retention time and relative retentions described in the method. Should this occur, it may be due to excessive dwell volume which is the volume between the point at which the 2 eluants meet and the top of the column.


GC

Column length: ± 70 per cent,
Column internal diameter: ± 50 per cent,
Particle size: maximal reduction of 50 per cent, no increase permitted,
Film thickness : −50 per cent to + 100 per cent.

Flow rate: ± 50 per cent.

Temperature: ± 10 per cent.

Injection volume: may be decreased, provided detection and repeatability are satisfactory.

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