SOP for Calibration of Gas Chromatograph : Pharmaceutical Guidelines

SOP for Calibration of Gas Chromatograph

Standard operating procedure to calibrate the Gas chromatograph with Ethanol as Internal Standard.

1.0 OBJECTIVE

To check the performance of equipment for reliable and accurate results.

2.0 SCOPE

This procedure is applicable to check the performance of Gas chromatograph, installed in the quality control department.

3.0 RESPONSIBILITY

3.1 Doing: Technical Assistant
3.2 Checking: Executive /Manager

4.0 ACCOUNTABILITY

Head of the Department

5.0 PROCEDURE

Frequency: Once in three months
5.1 Operate the instrument as per SOP
5.2 Prepare the solutions as follows.
5.2.1 INTERNAL STANDARD: Dilute 25 ml of Ethanol to 1000 ml with purified water.
5.2.2 TEST PREPARATION: Dilute each of 1ml, 2ml, 3ml, 4ml, 5ml methanol to 100ml with internal standard.
5.3 Follow the GC parameters as per given in Annexure I.
5.4 Inject 2.0 ml of test preparation and record the chromatographs.
5.5 Calculate the ratio of the area of Methanol v/s area of Internal standard
5.6 Calculate the Correlation Coefficient
5.6.1 Correlation Coefficient should be more than 0.9900.
5.6.2 The performance of the instrument is satisfactory if the obtained Correlation Coefficient is within the given limit, otherwise follow the S.O.P.

Related: SOP for Issuance, Maintenance & Disposal of HPLC / GC Columns

6.0 ABBREVIAITON

6.1 % = Percentage
6.2 ml = Mililiter
6.3 v/s = verses
6.4 GC = Gas Chromatograph

ANNEXURE-I
QUALITY CONTROL LABORATORY
PERFORMANCE CHECK REPORT OF GAS CHROMATOGRAPH
G.C.PARAMETERS:
Column                        : Porapack Q
Oven Temperature       : 150°C
Injector Temperature    : 200°C
Carrier                         : 30ml/min. (N2)
Injector Temperature    : 180°C
Injector volume            : 2.0ml
Preparation of internal Standard: 25 ml Ethanol à 1000ml with water
Test preparation: 1 ml, 2 ml, 3  ml, 4 ml, 5 ml Methanol à 100 ml with Internal Std.

Methanol (%v/v)
Area of Methanol
Area of Ethanol
Ratio=Area of Methanol
------------------------
Area of Ethanol
Mean Ratio
1.0%
1.
1.
1.
2.
2.
2.
2.0%
1.
1.
1.
2.
2.
2.
3.0%
1.
1.
1.
2.
2.
2.
4.0%
1.
1.
1.
2.
2.
2.
5.0%
1.
1.
1.
2.
2.
2.
   Correlation coefficient: ______________% (Not less than 0.9900)






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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