1.         OBJECTIVE

1. 1 To lay down a procedure for adjustment of chromatographic conditions for System suitability

2.         RESPONSIBILITY

2.1 Chemist / Executive –QC – To follow the SOP.   

2.2       In Charge / His Designee – QC – To ensure the compliance of SOP

3.         PROCEDURE

3.1    The various parameters of a chromatographic conditions shall be adjusted to  satisfy the system suitability criteria for particular analysis

3.2   The parameters shall be adjusted in order to ensure the separation required for satisfactory performance of the test or assay without fundamentally modifying the method

3.3  The adjustment of critical parameters shall be performed if they are clearly mentioned in the monograph in order to achieve the system suitability

3.4   The adjusting limits of parameters shall be followed as mentioned in annexure-1

3.5   Adjustments shall be permitted only if suitable standards (including reference standards) are available for all compounds used in the suitability test and are used to show that the adjustments have improved the quality of the chromatography in meeting system suitability requirements

3.6 Adjustments of Multiple parameters shall be avoided in order to avoid cumulative effect on the performance of the method.

3.7 The modified parameters shall be recorded in worksheet and method shall be  validated.

• Adjustments to chromatographic systems performed in order to comply with System suitability requirements should not be made to compensate for column failure or to circumvent replacing a deteriorated column.

• Adjustment of the various parameters in reverse phase liquid chromatographic methods will not always result in satisfactory chromatography. In that case, it may be necessary to change the column with another of the same type but from a different manufacturer.

4.     ABBREVIATIONS                                                  

4.1    QC – Quality Control.

5.     REFERENCES

• British Pharmacopoeia
• United states pharmacopoeia forum

6.         ANNEXURES

6.1       Annexure-1     Limits for adjusting parameters for system suitability

ANNEXURE – 1

Limits for Adjusting Parameters for System Suitability

Parameters	Thin Layer chromatography	High performance Liquid chromatography	Gas chromatography
Composition of Mobile Phase.	The amount of minor component  may be adjusted by ± 30% relative or ±2% absolute, whichever is larger .No other component is altered by more than 10 % absolute	The amount of minor component may be adjusted by ± 30% relative or ±2% absolute, whichever is larger .No other component is altered by more than 10 % absolute	Not Applicable
pH  of mobile phase	±0.2 pH, unless otherwise stated in the monograph or ± 0.1 pH for neutral substances	±0.2 pH, unless otherwise stated in the monograph or ± 0.1 pH for neutral substances	Not Applicable
Concentration of salts in the buffer component of Mobile phase	± 10%	± 10%	Not Applicable
Detector Wavelength	Not Applicable	No adjustment  permitted	Not Applicable
Stationary phase	As Mentioned in monograph	Column length :  ± 70 % Column I.D     :   ± 50 % Particle size     :   Maximal                              reduction of 50 %                              No  increase                               permitted	Column length :  ± 70 % Column I.D     :   ± 50 % Particle size     :   Maximal                              reduction of                             50 %,No                              increase                             Permitted Film Thickness  – 50 % to 100%
Flow Rate	Not Applicable	± 50 %	± 50 %

Parameters	Thin Layer chromatography	High performance Liquid chromatography	Gas chromatography
Temperature	Not Applicable	± 10 % , to a maximum of 60° C	± 10 %
Injection volume / Application volume	Decreased to 20 % of the prescribed Volume if using fine particle size plates ( 2-10 micron)	May be decreased, provided detection and repeatability of the peaks to be determined satisfactory	May be decreased, provided detection and repeatability of the peaks to be determined satisfactory
Column temperature	Not Applicable	Can be adjusted by as much as ± 20°. Column thermo stating to improve control and reproducibility of retention time	Can be adjusted by as much as ± 2 % in terms of absolute temperature
Oven temperature program	Not Applicable	Not Applicable	Can be adjusted by as much as ± 2 % in terms of absolute temperature. For the times specified for the temperature to be maintained or for the temperature to be changed from one to another, an adjusted of upto ± 20% is permitted

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