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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