Preparation, hahdling, storage and discard of mobile phases

Preparation, hahdling, storage and discard of mobile phases

• 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^H as 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

2. Composition
3. Prepared by
4. Date of preparation
5. Use before
6. 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

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