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

Ammonium Chloride

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General Notices

(Ph Eur monograph 0007)

NH4Cl    53.49     12125-02-9

Action and use

Used for the acidification of urine and to correct metabolic alkalosis.

Preparation

Ammonium Chloride Mixture

Ph Eur

DEFINITION
Content

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

CHARACTERS
Appearance

White or almost white, crystalline powder or colourless crystals.

Solubility

Freely soluble in water.

IDENTIFICATION

A. It gives the reactions of chlorides (2.3.1).

B. 10 mL of solution S (see Tests) gives the reaction of ammonium salts (2.3.1).

TESTS
Solution S

Dissolve 10.0 g in carbon dioxide-free water R prepared from distilled water R and dilute to 100 mL with the same solvent.

Appearance of solution

Solution S is clear (2.2.1) and colourless (2.2.2, Method II).

Acidity or alkalinity

To 10 mL of solution S add 0.05 mL of methyl red solution R. Not more than 0.5 mL of 0.01 M hydrochloric acid or 0.01 M sodium hydroxide is required to change the colour of the indicator.

Bromides and iodides

To 10 mL of solution S add 0.1 mL of dilute hydrochloric acid R and 0.05 mL of chloramine solution R. After 1 min, add 2 mL of chloroform R and shake vigorously. The chloroform layer remains colourless (2.2.2, Method I).

Sulfates (2.4.13)

Maximum 150 ppm.

Dilute 10 mL of solution S to 15 mL with distilled water R.

Calcium (2.4.3)

Maximum 200 ppm.

Dilute 5 mL of solution S to 15 mL with distilled water R.

Iron (2.4.9)

Maximum 20 ppm.

Dilute 5 mL of solution S to 10 mL with water R.

Heavy metals (2.4.8)

Maximum 10 ppm.

12 mL of solution S complies with test A. Prepare the reference solution using lead standard solution (1 ppm Pb) R.

Loss on drying (2.2.32)

Maximum 1.0 per cent, determined on 1.00 g by drying in an oven at 105 °C for 2 h.

Sulfated ash (2.4.14)

Maximum 0.1 per cent, determined on 2.0 g.

ASSAY

Dissolve 1.000 g in 20 mL of water R and add a mixture of 5 mL of formaldehyde solution R, previously neutralised to phenolphthalein solution R, and 20 mL of water R. After 1-2 min, titrate slowly with 1 M sodium hydroxide, using a further 0.2 mL of the same indicator.

1 mL of 1 M sodium hydroxide is equivalent to 53.49 mg of NH4Cl.

Ph Eur