Cupri-citric solution R1 Reagent Preparation SOP

Title: Standard operating procedure of Cupri-citric solution R1 preparation for laboratory use.

1.0  OBJECTIVE:
To lay down the procedure of Cupri-citric solution R1 for Laboratory use.
2.0  SCOPE:
This shall be applicable to the Quality Control Laboratory.
3.0  RESPONSIBILITY:
3.1  Q.C Analyst.
4.0  ACCOUNTABILITY:
4.1  Manager-Quality Control.
4.2  Head of the Q.C Department.
5.0  MATERIAL AND EQUIPMENT:
5.1  Glassware (3 beaker, 1 pipette, 1 spatula, 1 glass rod).
5.2  Magnetic stirrer.
5.3  Analytical weighing balance.
5.4  Titration apparatus.
5.5  Water-bath.
5.6  25.0g of copper sulphate R.
5.7  50.0g of citric acid R.
5.8  144.0g of anhydrous sodium carbonate R.
5.9  3.0g of potassium iodide R.
5.10    25.0ml of a 25% m/m solution of sulphuric acid R.
5.11    0.1M sodium thiosulphate.
5.12    0.5ml of starch solution R (as an indicator).
5.13    25.0ml of 0.1M hydrochloric acid.
5.14    0.1M sodium hydroxide.
5.15    Phenolphthalein solution R1 (as an indicator).
5.16    0.1M hydrochloric acid.
5.17    Purified water R (q.s.).
6.0  PROCEDURE:
6.1  Firstly weigh all ingredients by using analytical weighing balance operate according to SOP.
6.2  Take 1000.0ml of beaker and add 25g of copper sulphate R, 50.0g of citric acid R and 144.0g of anhydrous sodium carbonate R.
6.3  Add sufficient quantity of purified water R.
6.4  Mix it by using magnetic stirrer.
6.5  And dilute it to 1000.0ml with the same solvent.
6.6  Again mix it thoroughly by using magnetic stirrer.
6.7  Adjust the solution so that it complies with the following requirements:
6.7.1        Requirement 1:
6.7.1.1  Take a volumetric flask and add 25.0ml of above solution (6.1 to 6.6).
6.7.1.2  Add 3.0g of potassium iodide R.
6.7.1.3  Add 25.0ml of a 25% m/m solution of sulphuric acid R with precautions and in small quantities.
6.7.1.4  Set the titration apparatus.
6.7.1.5  Fill burette with 0.1M sodium thiosulphate.
6.7.1.6  Titrate with the titrant 0.1M sodium thiosulphate.
6.7.1.7  Use 0.5ml of starch solution R (as an indicator), added towards the end of the titration.
6.7.1.8  Results: 24.5ml to 25.5ml of 0.1M sodium thiosulphate is used in the titration.
6.7.2        Requirement 2:
6.7.2.1  Take a 10.0ml of above solution (6.1 to 6.6) in 100.0ml of beaker.
6.7.2.2  Dilute it to 100.0ml with purified water. Mix it by using magnetic stirrer.
6.7.2.3  Take again 10.0ml of this solution, add 25.0ml of 0.1M hydrochloric acid and heat for 1h on a water-bath.
6.7.2.4  Cool it.
6.7.2.5  Adjust with purified water R to the initial volume.
6.7.2.6  Set the titration apparatus.
6.7.2.7  Fill burette with 0.1M sodium hydroxide.
6.7.2.8  Use 0.1ml of phenolphthalein solution R1 (as an indicator).
6.7.2.9  Titrate with the titrant 0.1M sodium hydroxide.
6.7.2.10    Results: 5.7ml to 6.3ml of 0.1M sodium hydroxide is used in the titration.
6.7.3        Requirement 3:
6.7.3.1  Take a 10.0ml of above solution (6.1 to 6.6) in 100.0ml of beaker.
6.7.3.2  Dilute it to 100.0ml with purified water. Mix it by using magnetic stirrer.
6.7.3.3  Take again 10.0ml of this solution, in volumetric flask.
6.7.3.4  Set the titration apparatus.
6.7.3.5  Fill burette with 0.1M hydrochloric acid.
6.7.3.6  Use 0.1ml of phenolphthalein solution R1 (as an indicator).
6.7.3.7  Titrate with the titrant 0.1M hydrochloric acid.
6.7.3.8  Result: 6.0ml to 7.5ml of 0.1M hydrochloric acid is used in the titration.
7.0  REVISION LOG:
Revision No.
Effective Date
Reason
00

New SOP

8.0  REFERENCES:
8.1  The European Pharmacopoeia. Vol-1. Official Monograph /Reagents: 2015, pp.425-536.
9.0  ANNEXURES:
9.1  Not Applicable.
10.0    ABBREVIATIONS:
Abbreviation
Expanded Form
SOP
Standard operating procedure
&
And
No.
Number  
Ltd.
Limited
QCR
Quality control reagent
Q.C
Quality control
ml
Milliliter
Vol
Volume
q.s
Quantity sufficient
g
Grams
R
Reagent
R1
Reagent 1
%
Percentage
M
Molar


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