SOP FOR MOBILE PHASE PREPARATION


  1. OBJECTIVE
    :

    1. To lay down the procedure for the Preparation of Mobile Phase.

  2. SCOPE: 

    1. This procedure is applicable for the preparation of mobile phase for Chromatography Analysis being used in Quality Control Laboratory .

  3. RESPONSIBILITY:

    1. Quality Control Officer / Executive are responsible to follow procedure as per the procedure mentioned in this SOP. 

    2. QC Head is responsible for implementation and compliance of the procedure as per this SOP.

  4. ABBREVIATIONS

    1. SOP    :    Standard Operating Procedure

    2. QC    :    Quality Control

    3. STP    :    Standard  Test Procedure

  5. PROCEDURE

    1. Use appropriate grade of reagents as stated in the STP.

    2. Weigh the reagents accurately, dissolve and dilute with solvent as per the individual STP.

    3. Adjust the pH (if applicable) with appropriate reagent as per the STP.

    4. Mix thoroughly the buffer and solvents with the ratio mentioned in the individual STP and adjust the pH if it is mentioned in the STP. 

    5. Follow the same procedure for gradient buffer also and do the preparation separately STP.

    6. Prepare the quantity of mobile phase according to the sample load.

    7. Filter the mobile phase with 0.22 µm or 0.45 µm.

    8. Degas the mobile phase for about as per STP minutes by using Sonicator. 

    9. Label the mobile phase with following information, Product name, Test, prepared on and use Mobile Phase Label .

    10. If any visual turbidity is found during storage discard the mobile phase and prepare freshly.

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