QualityGuidances

• OBJECTIVE

To lay down a standard procedure for preparation & storage of mobile phase.

• SCOPE

This SOP is applicable for mobile phase preparation & storage in Quality Control Department

• RESPONSIBILITY
  • Officers / Executive – Quality Control shall be responsible for complies of this SOP
• ACCOUNTABILITY
  • Manager- Quality Control and Head QA shall be accountable for compliance of this SOP.
• ATTACHMENTS

Nil

• PROCEDURE
  • For normal-phase chromatography, less polar solvents are employed. The presence of water in the mobile phase is to be strictly controlled to obtained reproducible results.
  • In reverse-phased LC, aqueous mobile phases, with or without organic modifiers, are employed.
  • Components of the mobile phase are filtered through 0.45µm to remove particles greater than 0.45µm.
  • Multi component mobile phases are prepared by measuring the required volumes (unless masses are specified) of the individual components, followed by mixing. Alternatively, the solvents may be delivered by individual pumps controlled by proportioning valves by which mixing is performed according to the desired proportion.
  • Solvents are degassed before pumping by sonication, to avoid the creation of gas bubbles in the detector cell.
  • Solvents for the preparation of the mobile phase are normally free of stabilizers. Solvents should be HPLC grade quality.
  • Water should be used at low conductivity & low UV absorption (Double distilled /Milli-Q water).
  • If buffer solutions are used, adequate rinsing of the system is carried out with a mixture of water and the organic modifier of the mobile phase (5% v/v) to prevent crystallization of salts after completion of the chromatography.
  • Mobile phases may contain other components, e.g. a counter-ion for ion-pair chromatography or a chiral selector for chromatography using an achiral stationary phase.
  • Follow the procedure at particular product STP.
  • Use mobile phase within a week, filter if any turbidity is present after date of preparation.
  • If any particles and precipitate are found discard the same & prepare new mobile phase.
  • If pH of mobile phase is specified check the pH of the mobile phase before use.
• REFERENCES

In-house

    ABBREVIATIONS

SOP: Standard Operating Procedure

QC: Quality Control

STP: Standard Testing Procedure

HPLC: High Performance liquid Chromatograph

UV: Ultra-violet

OA: Quality Assurance

• DISTRIBUTION LIST

         Quality Assurance Department

Quality Control Department

 HISTORY OF REVISION

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