SOP for Calibration of Gas Chromatography

  1. OBJECTIVE:

To lay down a procedure for operation and calibration of Gas Chromatography.

  • SCOPE:

This procedure is applicable for procedure for operation and calibration of Gas Chromatography.

  • RESPONSIBILITY:

QC Officer/ QC Executive

  • ACCOUNTABILITY:

QC Manager.

  • PROCEDURE:
  • Precautions:Do not heat the G.C. column without passing carrier gas through the column.
  • Check the leakage of Hydrogen gas before putting the flame on.Check frequently the blue Silica gel of Gas filtration unit and  replace before it turns completely white.
  • Ensure that no air bubble is entrapped in syringe while injecting the sample.
  • If found any difficulty in operating the instrument or G.C. Solution software, and then refer the instrument manual.
  • Inform to the Department Head, If any abnormality is observed while working with Gas chromatograph
  •    Column Oven Temperature Calibration:  

               Ware google and gloves while handling glass wool.

                         Insert the calibrated thermometer from top side by piercing glass wool.

                         Set column oven temperature on GC to 500C, 1000C, 2000C, and 2500C.

                Allow to stabilize the set temperature for 5 min and record temperature on the

                       Digital thermometer and respective temperature.                                                                                        

  • Detector Calibration:
  • Operate the instrument as per its standard operating procedure.
  • Prepared the solution as follows:Prepare 1.0% v/v toluene in n-Hexane.
  • Follow the GC parameters as given:

Oven Temp.: 1100C(isothermal)

Injector Temp.: 1800C

Column Flow: 2.7 ml/min.

Run Time: 5 minutes.

Injector Volume: 0.5µl.

  • Inject the 0.5 ml of test preparation and record the chromatograph.
    • Inject blank and then six injections of 1.0% toluene solution in system and record chromatogram for all injections.
      • Calculate the RSD for the area of six 1.0% toluene injections.
      • The RSD should not be more then 15.0%.
      • Frequency of calibration is in every three month.
  • TRAINING:

Trainer   : Manager – Quality Control

Trainees : Staff of the QC departments

  • DISTRIBUTION:

Master Copy                  :           QA Department

Controlled Copy            :           QC Department

Display Copy                 :           QC Department (If Required)

  • ATTACHMENTS:
Sr. No. Title Annexure No.
01. NA NA
  • REFERENCES:

In-House

  1. ABBREVIATIONS:
Abbreviations Extended Form
SOP Standard Operating Procedure
NA Not Applicable
QC Quality Control
Sr. No. Serial Number
QA Quality Assurance
DEPT. Department
  1. REVISION HISTORY OF CHANGE:
Sr. No. Date Revision Details Revision No.

Gas chromatography

Chromatography

Column Chromatography

Bhanu Pratap Singh

BHANU PRATAP SINGH IS EXPERIENCED IN PHARMACEUTICAL, AUTHOR AND FOUNDER OF PHARMACEUTICAL GUIDESLINE (WWW.PHARMAGUIDESLINE.COM), A WIDELY READ PHARMACEUTICAL BLOG SINCE 2019. EMAIL:- INFO@PHARMAGUIDESLINE.COM

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