Cetrimide

Cetrimide is an antiseptic which is a mixture of different quaternary ammonium salts including cetrimonium bromide (CTAB). It is used as a 1-3 % solution for cleaning roadside accident wounds. It is also a surfactant, meaning it functions as a detergent with cleaning properties, with some industrial use. As a pharmaceutical ingredient, it is used in various products mainly for topical use in sprays, gels and creams for a range of purposes, including cleaning burns and wounds, for disinfecting skin before injections or surgery, and for treating fungal infections or nappy rash.

Properties and Specifications of Cetrimide or Myristyltrimethylammonium bromide or Tetradecyltrimethylammonium bromide or Tetradonium bromide:
Appearance: White or almost white, voluminous, free-flowing powder.
Assay: 99% minimum.
Solubility: Soluble in water and in alcohol.
Appearance of solution: Clear and colourless
Melting point: 247.5C literature.

Specifications of Cetrimide BP Ph Eur Grade:
Action and use: Antiseptic.

DEFINITION
Cetrimide consists of trimethyltetradecylammonium bromide and may contain smaller amounts of dodecyl- and hexadecyl-trimethylammonium bromides.
Content: 96.0 per cent to 101.0 per cent of alkyltrimethylammonium bromides, calculated as C17H38BrN (Mw 336.4) (dried substance).

CHARACTERS
Appearance: White or almost white, voluminous, free-flowing powder.
Solubility: Freely soluble in water and in alcohol.

IDENTIFICATION
A. Dissolve 0.25 g in alcohol and dilute to 25.0 mL with the same solvent. At wavelengths from 260 nm to 280 nm, the absorbance of the solution has a maximum of 0.05.
B. Dissolve about 5 mg in 5 mL of buffer solution pH 8.0. Add about 10 mg of potassium ferricyanide. A yellow precipitate is formed. Prepare a blank in the same manner but omitting the substance to be examined: a yellow solution is observed but no precipitate is formed.
C. Solution S (see Tests) froths copiously when shaken.
D. Thin-layer chromatography. To pass the test.
Result The principal spot in the chromatogram obtained with the test solution is similar in position, colour and size to the principal spot in the chromatogram obtained with the reference solution.
E. It gives reaction of bromides.

TESTS
Solution S: Dissolve 2.0 g in carbon dioxide-free water and dilute to 100 mL with the same solvent.
Appearance of solution: Solution S is clear and colourless.
Acidity or alkalinity: To 50 mL of solution S add 0.1 mL of bromocresol purple solution. Not more than 0.1 mL of 0.1 M hydrochloric acid or 0.1 M sodium hydroxide is required to change the colour of the indicator.
Amines and amine salts: Dissolve 5.0 g in 30 mL of a mixture of 1 volume of 1 M hydrochloric acid and 99 volumes of methanol and add 100 mL of 2-propanol. Pass a stream of nitrogen slowly through the solution. Gradually add 15.0 mL of 0.1 M tetrabutylammonium hydroxide and record the potentiometric titration curve. If the curve shows 2 points of inflexion, the volume of titrant added between the 2 points is not greater than 2.0 mL.
Loss on drying: Maximum 2.0 per cent, determined on 1.000 g by drying in an oven at 105C for 2 h.
Sulfated ash: Maximum 0.5 per cent, determined on 1.0 g.

ASSAY
Dissolve 2.000 g in water and dilute to 100.0 mL with the same solvent. Transfer 25.0 mL of the solution to a separating funnel, add 25 mL of chloroform, 10 mL of 0.1 M sodium hydroxide and 10.0 mL of a freshly prepared 50 g/L solution of potassium iodide. Shake and allow to separate and discard the chloroform layer. Shake the aqueous layer with 3 quantities, each of 10 mL, of chloroform and discard the chloroform layers. Add 40 mL of hydrochloric acid, allow to cool and titrate with 0.05 M potassium iodate until the deep brown colour is almost discharged. Add 2 mL of chloroform and continue the titration, shaking vigorously, until the colour of the chloroform layer no longer changes. Carry out a blank titration on a mixture of 10.0 mL of the freshly prepared 50 g/L solution of potassium iodide, 20 mL of water and 40 mL of hydrochloric acid.
1 mL of 0.05 M potassium iodate is equivalent to 33.64 mg of C17H38BrN.

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