POVIDONE IODINE METHOD OF ANALYSIS SOP


1.0  OBJECTIVE:
To lay down a procedure of analytical report for the active raw material of the Povidone-iodine from the Pharmacopoeial specifications.
2.0  SCOPE:
This SOP shall be applicable in Q.C laboratory.
3.0  RESPONSIBILITY:
3.1  Q.C Analysts.
4.0  ACCOUNTABILITY:
4.1  Q.C Manager
5.0  PROCEDURE:
5.1  Identification tests:
5.1.1        Material and equipment:
5.1.1.1.1        Glassware (according to requirement).
5.1.1.1.2        Starch.
5.1.1.1.3        Purified water.
5.1.1.2  Sample:
5.1.1.2.1        100mg/ml
5.1.1.3  Method of analysis:
5.1.1.3.1        Take a test tube and add 1 drop of the sample solution to a mixture of 1ml of starch and 9ml of water.
5.1.1.3.2        And observe the change in colour.
5.1.1.4  Acceptance criteria:
5.1.1.4.1        A deep blue colour is produced.
5.1.2         
5.1.2.1  Material and equipment:
5.1.2.1.1        Glassware (according to requirement).
5.1.2.1.2        needle
5.1.2.1.3        Purified water.
5.1.2.2  Sample:
5.1.2.2.1        100mg/ml
5.1.2.3  Method of analysis:
5.1.2.3.1        Take a glass-plate and spread 1ml of sample solution over an area of 20cm x 20cm on a glass plate.
5.1.2.3.2        And allow it to air-dry at room temperature in an atmosphere of low humidity overnight.
5.1.2.3.3        And observe its appearance closely.
5.1.2.3.4        And then add drops of water again observe it.
5.1.2.4  Acceptance criteria:
5.1.2.4.1        A brown, dry, non-smearing film is formed.
5.1.2.4.2        And it dissolves readily in water.
5.2  Assay:
5.2.1        Available iodine:
5.2.1.1  Sample:
5.2.1.1.1        5g of Povidone-iodine.
5.2.1.2  Material and equipment:
5.2.1.2.1        Glassware (according to requirement).
5.2.1.2.2        Purified water.
5.2.1.2.3        Sodium thiosulfate.
5.2.1.2.4        Starch.
5.2.1.3  Sample solution:
5.2.1.3.1        Take 500ml of beaker and place 5g of Povidone-iodine in it.
5.2.1.3.2        And add 200ml of water.
5.2.1.3.3        Cover the beaker.
5.2.1.3.4        And stir by mechanical means at room temperature for NMT 1hr to dissolve as completely as possible.
5.2.1.4  Titrimetric system:
5.2.1.4.1        Mode:
5.2.1.4.1.1  Direct titration.
5.2.1.4.2        Titrant:
5.2.1.4.2.1  0.1N sodium thiosulfate.
5.2.1.5  Method of analysis:
5.2.1.5.1        Set the apparatus according to the SOP.
5.2.1.5.2        Titrate the sample solution immediately with titrant.
5.2.1.5.3        Add 3ml of starch as the endpoint is approached.
5.2.1.5.4        Perform a blank determination and make any necessary correction.
5.2.1.5.5        Each ml of 0.1N sodium thiosulfate is equivalent to 12.69mg of iodine.
5.2.1.6  Acceptance criteria:
5.2.1.6.1        9.0%-12.0% of available iodine on the dried basis.
6.0  REVISION LOG:
Revision No.
Effective Date
Reason
00

New SOP

7.0  REFERENCES:
7.1  USP38NF33 Volume-6 Official Monograph/Povidone-iodine: 2015, pp.: 4956-4957.
8.0  ANNEXURES:
8.1  Not Applicable.


9.0  ABBREVIATIONS:
Abbreviation
Expanded Form
SOP
Standard operating procedure
&
And
No.
Number  
Ltd.
Limited
Q.C
Quality control
mg/ml
Milligram per milliliter
ml
Milliliter
cm
Centimeter
g
Gram
NMT
Not more than
hr
Hour
N
Normal
mg
Milligram
%
Percentage
QCA
Quality control active ingredient
F
Format


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