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SOP for Calibration of Autotitrator in Pharma


Standard operating procedure to calibrate the Autotitrator using Potassium Hydrogen Phthalate.

1.0 OBJECTIVE

To calibrate the equipment for reliable and accurate results.

2.0 SCOPE

This procedure is applicable to the Autotitrator in Quality Control..

3.0 RESPONSIBILITY

3.1 Doing : Technical Assistant
3.2 Checking : Executive/ Manager

4.0 ACCOUNTABILITY

Head of the Department

5.0 PROCEDURE

5.1 Frequency: Once in a 3 months.
5.2 Operate the instrument as per S.O.P.
5.2.1 Take potassium hydrogen phthalate previously dried at 105°C for 2 hrs. as the primary standard for titration.
5.2.2 Set the instrument parameter in MET mode.
5.2.3 Take 5 different accurate weight of primary standard varying from 0.1 to 0.3 gm.
5.2.4 Perform titration using standard 0.1 N Perchloric acid.
5.2.5 Refill the burette after each titration.
5.2.6 Report the results.
5.2.7 Calculate the linearity and correlation coefficient.
5.2.8 Linearity should not be less than 99.0%
5.2.9 Correlation coefficient should not be less than 0.9900%
5.2.10 The performance of the instrument is satisfactory if the obtained Linearity and Correlation Coefficient are within the given limit.
5.3 Calibration of the burette
5.3.1 Use 27°C water for calibration.
5.3.2 Mount the burette tip firmly on a stand rod. It must not be moved during the test.
5.3.3 Set dispensing and filling rate of the burette to “max”.
5.3.4 Take a dried beaker and tare the beaker.
5.3.5 Discharge the volume into the beaker and read off the value on the burette.
5.3.6 Press <FILL> Key.
5.3.7 Weigh the dispensed volume.
5.3.8 Repeat 5 discharges of different volume. Select size of the volume in random.
5.3.9 Calculate the V actual dispensed volume.
CALCULATION :
V ACTUAL = MASS X FACTOR OF WATER AT 27°C (1.0045)
V actual = Discharged volume in ml, calculated from the weighing data
MASS = Mass read off on the balance in gm.
5.3.10 Note down the reading.
5.3.11 Maximum relative error of the 20 ml exchange unit should be 0.15% and the deviation should be +/ - 30 µl.
5.3.12 The performance of burette is satisfactory if the obtained relative error and deviation should are within the given limit.
5.4 Affix calibration status label duly filled and signed on the equipment .

6.0 ABBREVIATION

6.1 °C = Degree centigrade
6.2 % = Percentage
6.3 gm. = Gram
6.4 ml = Millilitre

A)    Titrator Calibration
Balance Id No. : ___________
Ref. No. of  Potassium Hydrogen Phthalate : ___________
Actual Normality of 0.1 N Perchloric acid :___________                 
Sr.No.
Wt of Potassium Hydrogen Phthalate in mg
Burette reading at Ep1 in ml
1.     


2.     


3.     


4.     


5.     


Linearity  :


Acceptance Criteria:    Linearity : NLT 99.0% (Correlation coefficient : NLT 0.99000%)

B) Burette calibration :
   Balance Id No. : ___________

Sr.

No.

V set ml

Mass   g
V actual ml
Deviation
V actual – V set ml
Relative error %
1.     





2.     





3.     





4.     





5.     





Acceptance Criteria
±  30 µl
NMT 0.15%
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.
Email: .moc.enilediugamrahp@ofni Need Help: Ask Question


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