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SOP for Calibration of Polarimeter

OBJECTIVE
To lay down a procedure for Calibration of the polarimeter.

SCOPE
This procedure applies to the pharmaceutical manufacturing facilities of XYZ Limited.

RESPONSIBILITY
The Quality Control Chemist is responsible for implementation of the process.
The Quality Control Manager is responsible for the execution of the procedure.

PROCEDURE
  • Calibration of the polarimeter is done using previously dried analytical grade sucrose.
  • Prepare sucrose solutions of different concentrations in distilled water as per the Table 1 given below and measure the optical rotations.
  • Follow the SOP for the operation of the polarimeter for measurement of optical the rotation.
  • Compare the optical rotation observed with the standard readings in the table 1.
  • Observed optical rotation readings should fall within ± 3% of the standard reading. Otherwise label the instrument ‘Out of Order’ till necessary servicing is done and observed readings falls within the specified tolerance range.
  • Table 1: The table showing the sucrose solution concentrations with their respective optical rotations at 25oC

FREQUENCY
Calibrate the instrument once in six months and record results in the calibration log.

REFERENCE(s)
SOP : Operating procedure of polarimeter.

ABBREVIATION(s)
SOP : Standard Operating Procedure
Q.A : Quality Assurance
No. : Number
Q.C : Quality control
gm : Gram

ANNEXURE(s)
Polarimeter calibration log


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