Chloroxylenol Solution is a cutaneous solution.
Virgin Castor Oil
Terpineol 100 ml
Ethanol (96 per cent) 200 ml
Purified Water, freshly boiled and cooled Sufficient to produce 1000 ml
In making Chloroxylenol Solution, the Ethanol (96 per cent)
may be replaced by Industrial Methylated Spirit1.
The following directions apply.
Dissolve the Potassium Hydroxide in 15 ml of Purified Water,
add a solution of the Virgin Castor Oil in 63 ml of Ethanol (96 per cent), mix, allow to
stand for 1 hour or until a small portion of the mixture remains clear when diluted with 19 times its volume of Purified
Water and then add the Oleic Acid. Mix the Terpineol with a solution of the Chloroxylenol
in the remainder of the Ethanol (96 per cent), pour into the soap solution and add
sufficient Purified Water to produce 1000 ml.
The solution complies with the requirements stated
under Liquids for Cutaneous Application and with the following requirements.
Content of chloroxylenol, C8H9ClO
4.75 to 5.25% w/v.
16 to 21% v/v, Appendix VIII F.
Dissolve 0.4 g of 4-chloro-o-cresol (internal standard) in sufficient chloroform
to produce 50 ml (solution A). Carry out the method for gas chromatography,
Appendix III B, using solutions prepared in the following manner. For solution (1)
dissolve 0.10 g of chloroxylenol BPCRS in 10 ml of solution A and dilute to 20 ml
with chloroform. For solution (2) place 4 ml of the solution being examined in a
separating funnel, add 20 ml of chloroform, mix, add 4 ml of 2M hydrochloric acid and shake. Extract with
two further 10 ml quantities of chloroform. Combine the chloroform extracts, dry by
shaking with anhydrous sodium sulphate and filter. Prepare solution (3) in the same
manner as solution (2) but adding 20 ml of solution A in place of the 20 ml of chloroform.
The chromatographic procedure may be carried out using a glass
column (1.5 m 4 mm) packed with acid-washed, silanised diatomaceous support (80
to 100 mesh) coated with 3% w/w of polyethylene glycol (Carbowax 20M is suitable) and
maintained at 160.
Calculate the content of C8H9ClO using
the declared content of C8H9ClO in chloroxylenol BPCRS.
The label states (1) the date after which the solution is not
intended to be used; (2) the conditions under which it should be stored.
The label indicates the pharmaceutical form as 'cutaneous
1The law and statutory
regulations governing the use of Industrial Methylated Spirit must be observed.