SOP for Calibration of Refractometer in Pharmaceuticals : Pharmaceutical Guidelines

SOP for Calibration of Refractometer in Pharmaceuticals

Standard operating procedure for calibration of Refractometer.

1.0 Objective

To calibrate the equipment for confirmation of reliable and accurate results.

2.0 Scope

This procedure is applicable to calibrate the refractometer, installed in the quality control department.

3.0 Responsibility

3.1 Doing: Technical Assistant
3.2 Checking: Executive /Manager

4.0 Accountability

Head of the Department

5.0 Procedure

Frequency: Once in three months.
5.1 Operate the instrument as per S.O.P.
5.2 Maintain the required temperature of the particular liquid as mentioned in Annexure-I
5.3 Observe and record refractive index of the different liquid at temperature mentioned in Annexure-I.
5.4 The performance of the instrument is satisfactory if the observed refractive index is within the limits given in Annexure, otherwise follow the S.O.P.

6.0 Abbreviation

6.1 SOP - Standard Operating Procedure

ANNEXURE-I
QUALITY CONTROL LABORATORY

CALIBRATION REPORT OF REFRACTOMETER
CALIBRATION DATE
DATE OF LAST CALIBRATION DONE
NEXT DUE FOR
CALIBRATION




INSTRUMENT DETAILS
INSTRUMENT NAME

INSTRUMENT MAKE

INSTRUMENT
IDENTIFICATION NO.




OBSERVATION

Sr.No.
Liquid
Temperature
Observed Refractive index
Limit
01
Distilled water
20oC

1.330+0.0001
02
Carbon tetrachloride (AR grade)
20oC

1.459 – 1.461
03
Toluene (AR grade)
20oC

1.495-1.497





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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