SOP for Calibration of Refractometer in Pharmaceuticals

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

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