Preparation, hahdling, storage and discard of mobile phases

April 27, 2017February 3, 2023 Pharma Editor

OBJECTIVE
To lay down a procedure for the preparation , handling , storage and discard of mobile phases.
SCOPE
This SOP shall be applicable for preparation , handling , storage and discard of mobile phases.
RESPONSIBILITY
Executive/Officer – Quality control
ACCOUNTABILITY
Head – Quality Assurance
Procedure for preparation :
Weigh specified quantity of buffer ( solid ) or transfer the specified volume of buffer solution to the round bottom flask.
Add Milli Q water quantity sufficient to dissolve or mix the reagent buffer and sonicate the reagent. Adjust p^Has specified in individual monograph.(if required)
Add the organic solvent specified in individual monograph.
Filter the mobile phase using 0.45 µ filter and transfer to the mobile phase bottle. Label the bottle with details

1. Product

Composition
Prepared by
Date of preparation
Use before
Signature.

Sonicate for 10 minutes to degas the mobile phase.
Handling and Storage of mobile phase
Store the mobile phases in tightly closed containers when not in use.

The mobile phases that are under usage for dilution purposes should be closed properly.

Store the mobile phases prepared in large volumes in refrigerator when not in use. Allow the mobile phase to come to room temperature before usage.

Mobile phase shall be freshly prepared and should not be stored by more than24 hours.
Discard of mobile phases:
Any left over mobile phase and solvent discard from HPLC, sample preparation shall be drained in running tap water.
Wipe off the details on label & Clean the bottles using purified water, use laboratory reagent if required and rinse thoroughly using.
Dry the bottles and store them in appropriate place.

Forms and Records (Annexures)
Not Applicable
Distribution
Master copy – Quality Assurance
Controlled copies- Quality Assurance, Production, Quality Control.engineering
History

Date Revision Number Reason for Revision

– 00 New SOP

Date	Revision Number	Reason for Revision
–	00	New SOP

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