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polycao金虫 (小有名气)
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欧洲药典EP5.4关于液相条件可适当调整的规定
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中国药典附录规定色谱柱长度,流动相比例可适当调整,但没有明确规定调整多少算是适当. 以下是欧洲药典EP5.4关于液相条件可适当调整的规定,也许可以作为参考: Liquid chromatography 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 (see example above). No other component is altered by more than 10 per cent 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. Detector wavelength : no adjustment permitted. 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. |
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