• British Pharmacopoeia Volume I & II
  • Monographs: Medicinal and Pharmaceutical Substances

Zinc Oxide

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General Notices

(Ph. Eur. monograph 0252)

ZnO    81.4    1314-13-2

Action and use

Mild astringent.

Preparations

Zinc Cream

Coal Tar and Zinc Ointment

Zinc Ointment

Zinc and Castor Oil Ointment

Compound Zinc Paste

Zinc and Salicylic Acid Paste

Zinc and Coal Tar Paste

Ph Eur

DEFINITION
Content

99.0 per cent to 100.5 per cent (ignited substance).

CHARACTERS
Appearance

Soft, white or faintly yellowish-white, amorphous powder, free from gritty particles.

Solubility

Practically insoluble in water and in ethanol (96 per cent). It dissolves in dilute mineral acids.

IDENTIFICATION

A. It becomes yellow when strongly heated; the yellow colour disappears on cooling.

B. Dissolve 0.1 g in 1.5 mL of dilute hydrochloric acid R and dilute to 5 mL with water R. The solution gives the reaction of zinc (2.3.1).

TESTS
Alkalinity

Shake 1.0 g with 10 mL of boiling water R. Add 0.1 mL of phenolphthalein solution R and filter. If the filtrate is red, not more than 0.3 mL of 0.1 M hydrochloric acid is required to change the colour of the indicator.

Carbonates and substances insoluble in acids

Dissolve 1.0 g in 15 mL of dilute hydrochloric acid R. It dissolves without effervescence and the solution is not more opalescent than reference suspension II (2.2.1) and is colourless (2.2.2, Method II).

Arsenic (2.4.2, Method A)

Maximum 5 ppm, determined on 0.2 g.

Cadmium

Maximum 10 ppm.

Atomic absorption spectrometry (2.2.23, Method II).

Test solution  Dissolve 2.0 g in 14 mL of a mixture of equal volumes of water R and cadmium- and lead-free nitric acid R, boil for 1 min, cool and dilute to 100.0 mL with water R.

Reference solutions  Prepare the reference solutions using cadmium standard solution (0.1 per cent Cd) R and diluting with a 3.5 per cent V/V solution of cadmium- and lead-free nitric acid R.

Source  Cadmium hollow-cathode lamp.

Wavelength  228.8 nm.

Atomisation device  Air-acetylene or air-propane flame.

Iron (2.4.9)

Maximum 200 ppm.

Dissolve 50 mg in 1 mL of dilute hydrochloric acid R and dilute to 10 mL with water R. Use in this test 0.5 mL of thioglycollic acid R.

Lead

Maximum 50 ppm.

Atomic absorption spectrometry (2.2.23, Method II).

Test solution  Dissolve 5.0 g in 24 mL of a mixture of equal volumes of water R and cadmium- and lead-free nitric acid R, boil for 1 min, cool and dilute to 100.0 mL with water R.

Reference solutions  Prepare the reference solutions using lead standard solution (0.1 per cent Pb) R and diluting with a 3.5 per cent V/V solution of cadmium- and lead-free nitric acid R.

Source  Lead hollow-cathode lamp.

Wavelength  283.3 nm; 217.0 nm may be used depending on the apparatus.

Atomisation device  Air-acetylene flame.

Loss on ignition

Maximum 1.0 per cent, determined on 1.00 g by ignition to constant mass at 500 ± 50 °C.

ASSAY

Dissolve 0.150 g in 10 mL of dilute acetic acid R. Carry out the complexometric titration of zinc (2.5.11).

1 mL of 0.1 M sodium edetate is equivalent to 8.14 mg of ZnO.

Ph Eur