SOP for Calibration of Infrared Spectrophotometer : Pharmaceutical Guidelines

SOP for Calibration of Infrared Spectrophotometer

Standard operating procedure of calibration of Infrared Spectrophotometer.

1.0 OBJECTIVE

To calibrate the equipment for reliable and accurate results.

2.0 SCOPE

This procedure is applicable to the infrared spectrophotometer, 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 of calibration: Once in a month
5.1 Operate the instrument as per SOP.
5.2 Put the reference polystyrene film (0.05 mm thick) in the sample holder and scan.
5.3 Compare the obtained spectrum with the reference spectrum for the following wave numbers as well as transmittance at shown wave number. Record the results as per annexure I.
5.3.1  Sr. No.    Wave number                                      % T
          01            1583 cm-1 to 1589 cm-1                       greater than 12%
          02            2851 cm-1 to 2870 cm-1                       greater than 18 %         
5.3.2  Sr. No.    Wave numbers of Reference Polystyrene film [Limit + 5 cm1 ]
           1                      3027.1                                                                       
           2                      2924.0                                                                       
           3                      2850.7                                                                       
           4                      1944.0                                                                        
           5                      1871.0                                                                       
           6                      1801.6                                                                        
           7                      1601.4                                                                       
           8                      1583.1                                                                       
           9                      1181.4                                                                       
          10                     1154.3                                                                       
          11                     1069.1                                                                       
          12                     1028.0                                                                       
          13                      906.7                                                                         
          14                      698.9                                                                        
5.4 The performance of the instrument is satisfactory, if obtained I.R. Spectrum shows peaks at above wave numbers, otherwise follow the S.O.P.

6.0 ABBREVIATIONS

6.1 % = Percentage
6.2 I.R = Infra red
6.3 S.O.P. = Standard operating procedure

ANNEXURE-I
QUALITY CONTROL LABORATORY

CALIBRTAION REPORT OF INFRARED SPECTROPHOTOMETER
CALIBRATION DATE

DATE OF LAST CALIBRATION DONE
NEXT DUE FOR
CALIBRATION



INSTRUMENTS DETAILS
INSTRUMENT NAME

INSTRUMENT MAKE

INSTRUMENT
IDENTIFICATION



OBSERVATION
For  Transmittance 
Sr.No.
At wave number            
% T
% T
 01           
1583 cm-1 to 1589 cm1

greater than 12%
 02 
2851 cm-1 to 28701

greater than 18 %         
For wave numbers
   Sr. No.   
Wave numbers of Reference Polystyrene film
Observation
Limit
01
3027.1







+ 5 cm-1
02
2924.0

03
2850.7

04
1944.0

05
1871.0

06
1801.6

07
1601.4

08
1583.1

09
1181.4

10
1154.3

11
1069.1

12
1028.0

13
906.7

14
698.9

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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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