Compound Benzoic acid Ointment BP.pdf

Pharmaceutical Technology

1. Compound Benzoic Acid Ointment BP
(Whitfield’s Ointment)

I. Objective
To prepare Compound Benzoic acid ointment

II. Overview of Whitfield’s Ointments
Whitfield's ointment, an effective antifungal topical preparation, contains a
mixture of Benzoic acid and Salicylic acid in the ration of 2:1 in a suitable base.

III. Materials
N° Components Function Percentage (%) Qty./Item (g)
1 Benzoic acid API 6 3
2 Salicylic acid API 3 1.5
3 Paraffin oil Base 5 2.5
4 Vaseline Base 86 43

IV. Equipment
N° Equipment Quantity
1 Balance 1 Pc
2 Weighing paper 1 Box
3 Spatula 2 Pcs
4 Beaker 250 mL 1 Pc
5 Mortar and Pestle 1L 1 Set
6 Syringe 10 cc 1 Pc
7 Plastic tube or Jar 1 Pc

2. V. Manufacturing Process
Step Process Equipment Verification
1 Verify equipment - Cleanness
Sufficient
2 Weigh raw materials Balance
Spatula
Weighing paper
-
3 Mix Benzoic acid with Salicylic acid Mortar and Pestle Homogeny
4 Add Paraffin oil into Mortar and continue
mixing
Mortar and Pestle Homogeny
5 Add some part of Vaseline into the mixture Mortar and Pestle Homogeny
6 Add the left amount of Vaseline then mix
until homogeny
Mortar and Pestle Homogeny
7 Pure the mixture into container Plastic tube / Jar -

VI. In Process Control
Appearance: Oily white semi-solid form

VII. Labeling
1. Manufacturing place:
2. Product Name with strength
3. Manufacturing date:
4. Prepared by:
5. Indication
For the treatment of ringworm and other fungal skin infections

Reference:
Marriott, J.F. (Ed.), 2010. Pharmaceutical compounding and dispensing, 2nd ed.
Pharmaceutical Press, London.