sop for preparation of mobile phase


sop for preparation of mobile phase


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

Officer / Executive – QC

Head – QC


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:

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.

QC – Quality Control

QA – Quality Assurance
SOP – Standard Operating Procedure

ml – Mililiter


Annexure – I Mobile Phase Label
Annexure – I Mobile Phase Preparation Record

• Controlled Copy      : Head Quality Control
• Master Copy             :Quality Assurance




Revision no. Change control NO. Details of changes Reason of changes Effective date Done by
      00 Not applicable Not applicable New sop


Annexure – I


B.NO. /AR NO. -:
Format No.: ……………..






SOP for testing of ETP water

sop for Calibration and Maintenance of Laboratory Instruments and Equipment

Disposal of Residual Sample or Left Over Material

sop for for Laboratory Incident

standard operating procedure temperature monitoring

sop for drying of silica gel

sop for operation of infrared moisture balance

sop for preparation of mobile phase

sop for treated RO water

sop for Preparation and Issuance of Analysis protocol standard

sop of placebo and impurity stock solutions

sop for disposal of residual sample  

sop for handling of pharmacopoeial changes

sop for procedure for operation of ultrasonic cleaner

difference between UPLC and HPLC

sop for for Emergency Eyewash and Shower

sop for operation and calibration of total organic carbon analyzers

sop for operation of cobb tester

sop for Operation and calibration of atomic absorption spectrophotometer

sop for Operation and calibration of gas liquid chromatograph

sop for operation of humidity oven

sop for operation and calibration of serological water bath

sop for monitoring of drain trap

sop for destruction of analytical samples after testing and control samples

sop for destruction of used chemicals

Sop for Operation of suction pump

sop for Operation and calibration uv cabinet

sop for Operation and calibration of bulk density apparatus

sop for operation and calibration of shore hardness tester

sop for operation of rub proofness tester

sop for monitoring of purified water

sop for Retesting of packaging materials

sop for Retesting and resampling of raw materials

sop for Control of issuance of record of analysis green sheets

sop for Control of computer passwords

sop for sampling of packaging materials PM

sop for sampling of sterile raw material

sop for sampling of intermediates and finished products

sop for operation and calibration of friability test apparatus

sop for approval and rejection of packaging materials

sop for non conformance of RM PM and finished product

sop for collection storage and disposal of control samples

sop for trend analysis of finished products

sop for Chromatographic practices and system suitability

SOP For Good Laboratory Practices

sop for cleaning and operation of sieve shaker

general specification of packing material cartons

sop for Password for Analytical Instrument and LIMS software

sop for Rounding off numerical analytical results

sop for sampling of bulk and finished product

sop for cleaning of spillage material

sop for Handling of Reference Standard

sop for hplc column maintenance and washing

procedure for sampling and handling of bulk sample

STP for borewell generation point (raw water storage tank)

sop for preparation and standardization of 0.1M Zinc Sulphate

Operation &calibration of analytical balance (dhona)

Operation and Calibration Procedure for Disintegration Test apparatus

sop for preparation and standardization of 1 M Hydrochloric Acid

Preparation and standardization of 0.1 M ceric ammonium sulphate solution

sop for preparation and standardization of 0.05 m iodine solution

validation of volumetric solution 0.1m ammonium thiocyanate

handling of reference standard and preparation of working standard

sop for water sampling and analysis

sop for operation for validation of excel worksheets

sop for laboratory cleaning

sop for stability of volumetric solutions

sop for preparation of raw material in process finish product packing material data sheets

sop for handling of hazardous chemicals

sop for handling of glassware and allocation of identification number

sop for operation cleaning and calibration of bursting strength tester

sop for rounding off the analytical test results

procedure for Analyst Qualification

sop for operation and calibration of dissolution Apparatus

procedure for maintenance of desiccators

sop for for hplc column receipt checking id no and regeneration

safety data sheet for laboratory chemicals

procedure for handling of poisonous chemicals

sop for cleaning of sampling devices

sop for calibration procedure of instruments

sop for specification and standard testing raw material packing material and finished product

procedure for operation and calibration of potentiometric titrator

procedure for operating and calibration of digital hardness tester

procedure for disposal of expired chemicals, reagents and solvents

sop for behavior in quality control department

sop for preparation and standardization 0.1M sodium thiosulphate

sop for preparation and standardization 0.1M Disodium Edetate

preparation and standardization 0.1M Sodium Hydroxide Solution

Preparation and standardization of 0.1M Perchloric acid solution

sop for preparation 0.05M edetate disodium

sop for preparation 0.1M silver nitrate

sop for Operation and Calibration of High Performance Liquid Chromatography

sop for UV & Visible Spectrophotometer

procedure for Cleaning of laboratory glassware

Cleaning of Instrument, Instrument bench and surrounding area of Quality

Safety Precaution in Quality Control Department

Operation & Calibration of Analytical Balance

Calibration of Glassware in Quality Control Department

handling of samples received in Quality Control

Cleaning and Operation of Refrigerator

Operation, Cleaning and Calibration of water bath

Operation & Calibration of Refractometer

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

Operation Cleaning and Calibration of Muffle Furnance in Quality Control Department

procedure of operation and Cleaning of Sonicator

Operation Cleaning & Calibration of pH meter in Quality Control Department

Entry and Exit in Quality Control Department
































































































































Leave a Comment

error: Content is protected !!