Procedure for preparation and standardization 0.1 N Iodine

1. OBJECTIVE
To lay down the procedure for preparation and standardization of 0.1 N Iodine

2. SCOPE
This procedure is applicable to Quality Control Department

3. RESPONSIBILITY
• Officer QC
• Manager QC

4. SAFETY INSTRUCTIONS
• Proper handling the apparatus.
• Always wear appropriate personal protective equipment when handling this chemical.
Always handle the chemicals with care and dispose of any waste properly.
• Additionally, it is important to weigh the chemicals accurately and dissolve them completely to ensure the desired concentration of the solution.
• Preserve in amber-colored, glass-stoppered bottles.

5. PROCEDURE
5.1 PREPARATION
5.1.1 5.1.1 Weigh 40 g of potassium iodide (KI) in a 500 mL glass-stoppered flask and dissolve in 100 mL of purified water.
5.1.2 Let the solution come to room temperature, add 12.7 g of resublimed iodine (I2), restopper the flask, and swirl the flask until the iodine is completely dissolved.

5.2 STANDARDIZATION
5.2.1 Transfer 25.0 mL of the iodine solution to a 250-mL flask, dilute with water to 100 mL, add 1 mL of 1 N hydrochloric acid, swirl gently to mix, and titrate with 0.1 N sodium thiosulfate VS until the solution has a pale yellow color.
5.2.2 Add 2 mL of starch TS and continue titrating until the solution is colorless.
5.2.3 And calculate the normality by the following formula:

        ml Na2S2O3 x N Na2S2O3
N= ————————————-
         25

6. RELATED DOCUMENTS
N/A

7. DISTRIBUTION INDEX
Original Copy will be retained by Quality Assurance Department.

DISTRIBUTION INDEX
Distributed To Copy No. Received By/Date
Quality Control Department 01 ,

8. ABBREVIATIONS
Q.C Quality Control Department
TS Test Solution
Gm Gram
ml Milliliter

9. REVISION HISTORY

Revision No. Issue Date Supersedes Reason of Change / Description
          Revision No.              Dated     
00 10/02/2023 00                            N/A First Version

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Pharmaceutical Services

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