• British Pharmacopoeia Volume III
  • Formulated Preparations: Specific Monographs

Liquid Paraffin Oral Emulsion

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General Notices

Liquid Paraffin Emulsion

Definition

Liquid Paraffin

500 mL

Vanillin

500 mg

Chloroform

2.5 mL

Benzoic Acid Solution

20 mL

Methylcellulose 20

20 g

Saccharin Sodium

50 mg

Water

A sufficient quantity

Extemporaneous preparation

The following directions apply.

Heat about 120 mL of Water until it boils and add the Methylcellulose; when thoroughly hydrated add sufficient Water in the form of ice to produce 350 mL and stir until homogeneous. Mix the Chloroform and the Benzoic Acid Solution, dissolve the Vanillin in the mixture and add to the methylcellulose dispersion while stirring vigorously for 5 minutes. Add the Saccharin Sodium dissolved in Water and dilute to 500 mL with Water. Add the Liquid Paraffin, stirring constantly, and pass through a homogeniser.

The oral emulsion complies with the requirements stated under Oral Liquids and with the following requirements.

Content of liquid paraffin

44.0 to 49.0% w/w.

Assay

To 5 g add 10 mL of water, extract with two 40 mL quantities of a mixture of 2 volumes of ethanol (96%), 3 volumes of petroleum spirit (boiling range, 40° to 60°) and 3 volumes of ether and then with 30 mL of a mixture of equal volumes of petroleum spirit (boiling range, 40° to 60°) and ether. Wash the combined extracts with 15 mL of 0.5m sodium hydroxide and then with 15 mL of water, evaporate the solvent, add 5 mL of acetone and evaporate again. Repeat the addition and evaporation of acetone until the residue is free from water, dry at 105° for 15 minutes and weigh.