sop for preparation of mobile phase
1.0 OBJECTIVE:
To lay down a procedure for the Procedure for preparation of mobile phase in Quality Control department during analysis.
2.0 SCOPE:
This SOP procedure is applicable for Quality Control Department
3.0 RESPONSIBILITY:
Officer / Executive – QC
4.0 ACCOUNTABILITY:
Head – QC
5.0 PROCEDURE:
Read the respective testing procedure for preparation of Mobile phase.
Mobile phase shall be prepared freshly for analysis.
Take the required chemicals from reagent rack.
Calculate the quantity of mobile phase required for analysis.
Calculate the quantity of chemical/reagent as per require for preparation of buffer solutions and organic solvent.
Weigh accurately quantity of chemical / reagent and make dilutions to get the required strength
/Molarity as per respective testing procedure. (Specific ratio given in respective testing procedure of product to be analyzed).
Sonicate well to dissolve (Sonication apply only on mobile phase) and make sure that there are no un-dissolved chemical remains in the flask.
Make the necessary adjustment to attain the required pH
Measure the required portion of organic solvent using the same measuring cylinder and transfer it to the same mobile phase reservoir. (Specific ratio given in respective testing procedure of product to be analyzed).
Shake well to mix properly
Observe that there is no precipitation.
If precipitation is observed repeat the procedure precisely and avoid the mistakes if any.
Transfer the dissolution medium in vessels by using measuring cylinder and maintain a record as per annexure-2.
Filter mobile phase through 0.45µm filter paper in a clean and dry filtration flask.
Rinse the filtration flask approximately 50 ml portion of filtrate.
Transfer the filtered solution in a clean and dry mobile phase reservoir.
Sonicate the prepared mobile phase for about 10 minutes to make the solution bubble free. (if required increase the sonication time).
After sufficient sonication, assure no any air bubbles in the mobile phase then use the mobile phase for analysis and maintain record as per annexure-1.
Paste the label on mobile phase reservoir:
Precautions:
Always use clean and dry glassware.
Ensure that correct chemical/reagent is taken as per required specification.
Always take a fresh membrane filter paper.
If any physical contamination is observed, prepare again fresh mobile phase.
Label the reservoir immediately after transfer of mobile phase.
6.0 ABBREVIATIONS
QC – Quality Control
QA – Quality Assurance
SOP – Standard Operating Procedure
ml – Mililiter
7.0 ANNEXURES
Annexure – I Mobile Phase Label
Annexure – I Mobile Phase Preparation Record
8.0 DISTRIBUTION:
• Controlled Copy : Head Quality Control
• Master Copy :Quality Assurance
9.0 REFERENCES:
In-House
10.0 REVISION HISTORY:
| Revision no. | Change control NO. | Details of changes | Reason of changes | Effective date | Done by |
| 00 | Not applicable | Not applicable | New sop |
Annexure – I
| MOBILE PHASE |
| HPLC ID-: |
| NAME OF PRODUCT-: |
| B.NO. /AR NO. -: |
| TEST-: |
| PREPARED BY-: |
| DATE-: |
| Format No.: …………….. |
|
|
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sop for preparation of mobile phase
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sop for destruction of analytical samples after testing and control samples
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sop for operation and calibration of shore hardness tester
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sop for collection storage and disposal of control samples
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Calibration of Glassware in Quality Control Department
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Operation and Cleaning of Centrifuge Apparatus
cleaning, operation & calibration of Vernier caliper
Calibration of Fourier Transform Infrared Spectrophotometer (FTIR)
Cleaning and operation of Moisture Analyzer
Cleaning & Operation of Vacuum pump in Quality Control Department
Operation and Calibration of Polarimeter
Cleaning and operation of Magnetic Stirrer
Cleaning Operation and Calibration of Melting Point
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procedure of operation and Cleaning of Sonicator
Operation Cleaning & Calibration of pH meter in Quality Control Department
Entry and Exit in Quality Control Department