SOP for Calibration of Gas Chromatograph | Pharmaguideline
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  • Apr 17, 2021

    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)

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