Procedure for Optical Rotation Testing
1) Purpose
The purpose of this SOP is to outline the procedure for determining the optical rotation of pharmaceutical substances using appropriate analytical techniques.
2) Scope
This SOP applies to all pharmaceutical substances within the facility that require optical rotation testing as part of quality control, following pharmacopeial guidelines and internal specifications.
3) Responsibilities
Quality Control (QC) Department: Responsible for performing optical rotation testing and ensuring compliance with this SOP.
Analytical Laboratory: Responsible for conducting analysis using suitable techniques and interpreting results accurately.
4) Procedure
4.1 Instrument Setup:
4.1.1 Ensure the polarimeter or spectrometer is calibrated according to manufacturer instructions and method validation protocols.
4.1.2 Verify the cleanliness and condition of the polarimeter cell or sample chamber.
4.1.3 Stabilize the instrument at the specified temperature for accurate measurements.
4.2 Sample Preparation:
4.2.1 Obtain representative samples of pharmaceutical substances requiring optical rotation analysis.
4.2.2 Label samples with batch numbers, dates, and any other relevant information.
4.2.3 Ensure samples are at the specified temperature for analysis to minimize temperature-related errors.
4.3 Measurement Procedure:
4.3.1 Place the sample solution or sample in the polarimeter cell and adjust the instrument to zero rotation with the blank solvent or reference solution.
4.3.2 Measure the optical rotation angle of the sample by rotating the analyzer until the rotation of the sample is compensated.
4.3.3 Record the optical rotation angle displayed on the instrument, ensuring accurate reading and notation of any adjustments.
4.4 Calibration Verification:
4.4.1 Periodically verify the accuracy of the polarimeter by measuring certified reference standards with known optical rotation values.
4.4.2 Document calibration verification results and adjust instrument settings if deviations are observed.
4.4.3 Maintain records of calibration checks to ensure ongoing accuracy and traceability.
4.5 Calculation and Documentation:
4.5.1 Calculate and report the average optical rotation angle based on repeated measurements.
4.5.2 Document all optical rotation testing procedures, instrument settings, and results in the Optical Rotation Testing Report.
4.5.3 Review and approve the documentation by QC Manager before releasing results.
5) Abbreviations, if any
QC: Quality Control
6) Documents, if any
Optical Rotation Testing Report
Instrument Calibration Records
Method Validation Protocol and Report
7) Reference, if any
USP General Chapter <781> – Optical Rotation
Pharmacopeial standards for optical rotation determination in pharmaceutical substances
8) SOP Version
Version 1.0
