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PVP Iodine 10%

This document provides a manufacturing formula and process for producing 1000 ml of a 10% povidone iodine solution. It lists the raw materials, quantities, and preparation steps which involve dissolving ingredients in water, adjusting the pH, and mixing until homogeneous before filling and labeling bottles for storage and distribution. Quality checks are performed throughout production and on the final batch to ensure standards are met before release.

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227 views1 page

PVP Iodine 10%

This document provides a manufacturing formula and process for producing 1000 ml of a 10% povidone iodine solution. It lists the raw materials, quantities, and preparation steps which involve dissolving ingredients in water, adjusting the pH, and mixing until homogeneous before filling and labeling bottles for storage and distribution. Quality checks are performed throughout production and on the final batch to ensure standards are met before release.

Uploaded by

Trần Văn Lộc
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOC, PDF, TXT or read online on Scribd
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Povidone iodine solution 10% Batch quantity 1000 ml Master manufacturing formula

approved by
Prepared by:
Preparation date: Source master manufacturing
Batch number: formula: Dermatological preparations
for the tropics, 2nd ed.

Raw materials and packaging materials


Quantity Source and batch Actual quantity Initials weighing Initials control
prescribed number weighed/measured
Povidone iodine 110 g
Sodium dihydrogen phosphate 13.6 g
anhydrous
Citric acid monohydrate 8.8 g
Water to 1000 ml

Dark coloured glass bottle(s)

Preparation In-process checks


1. Boil 1200 ml water for 1 minute and allow to cool. Use this water for the preparation. Water boiled? yes/no
2. Dissolve the sodium dihydrogen phosphate and the citric acid in approx. 70 ml water. Completely yes/no
dissolved?
3. If possible check the pH value. It should be approx. 5. Adjust if necessary (with diluted sodium pH value:
hydroxide solution or diluted hydrochloric acid solution).
4. Slowly add the povidone iodine while stirring.
5. Continue stirring until homogeneous. Homogeneous? yes/no
6. Calibrate a bottle or vessel for 1000 ml. Calibration control
7. Pour the mixture into the calibrated bottle or vessel and make up to volume with water Final volume: ml
to 1000 ml.

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Storage condition in a dark place below 35 °C Yield


Shelf life 3 months Loss
Expiry date Loss due to

End controls before release of batch Checked by Result


Batch numbers raw materials correct?
Packaging materials correct, in good condition and closed properly?
Labelling conform model?
Expiry date stated correctly?
Dark brown liquid?
Are all boxes of this form filled correctly and completely?

Batch released by (name and signature) Date:

Model of label for stock Model of label for the patient


For external use only For external use only
Povidone iodine solution 10% Dispensing unit and date
Batch number and batch date Povidone iodine solution 10%
Do not use past: (production date + 3 months) Patient name
Store in a dark place below 35 °C Wash the wound and apply the solution. Do not cover with a
bandage.
Do not use past (production date + 3 months)

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