SOP for Verification of System Suitability Test Measured by Chromcard Software for GC

1.0 OBJECTIVE

To Verify system suitability values manually v/s software.

2.0 SCOPE

This procedure is applicable to verify system suitability software results Vs manually Chrom card software of gas chromatograph.

3.0 RESPONSIBILITY

3.1 Doing: Technical Assistant
3.2 Checking: Executive/ Manager

4.0 ACCOUNTABILITY

Head of the Department

5.0 PROCEDURE

5.1 Frequency: Once in 6 months.
5.2 Operate the instrument as per the respective standard operating procedure of GC.
5.3 For solution preparation and instrument condition follow the respective procedure of calibration of respective instruments.
5.4 Record the area and retention time of both Methanol and Ethanol.
Calculate the system suitability parameters with the help of software such as resolution, tailing factor and theoretical plate.
5.5 Now calculate the tailing factor, resolution and theoretical plate manually by the following formula

Theoretical Plate :  N = 16 (t/w)²

                                                                Where t = R.T of  the component

                                                             w = width of the component

Resolution :  2(t₂ – t₁)/w₁ + w₂        Where t₁ = R.T of I^st components

                                                                       t₂ = R.T of II^nd components               

                                                              w₁ = Width of I^st components

                                                              w₂ = Width of II^nd component  
Tailing :  T =  w/2f

                                                   Where  w = width of peak

                                                               f  = width of half peak at 5 % height                                                                                                        

5.6 The performance of software of the instrument is satisfactory if the all the parameters of the system suitability test are within the acceptance criteria.
5.7 Acceptance criteria: Difference should be within +/- 10.0 %

6.0 ABBREVIATION

6.1 % = Percentage
6.2 ml = millilitre
6.3 RT = Retention time

  Verification of system suitability parameters

  Name of software :___________

1)     Resolution :

        As per software  = _________________

                                             2 (t₂ – t₁)

        By manually  =  R  =  ------------------

                                             w₁ + w₂

                                                       =   ----------------- ( +/- 10 %)

2)     Tailing  :

   As per software = ________________

   By manually      =    T =  w/2f

                    

                                = ------------------------( +/- 10%)            

3)     Theoretical Plate :                       

        As per software =______________                        

        By manually      =    N = 16 (t/w)²

                               

                                   = ------------------------ ( +/- 10%)

        Remarks: Comply/Does not comply

Get ready to use editable documents in MS-Word FormatView List

Share

Tweet

Share

Share