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

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

Standard operating procedure to verify system suitability software results Vs manually Chrom card software of gas chromatograph.

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 t= R.T of Ist components
                                                                       t2 = R.T of IInd components               
                                                              w1 = Width of Ist components
                                                              w= Width of IInd 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

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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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