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

Sodium Bicarbonate

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General Notices

(Sodium Hydrogen Carbonate, Ph Eur monograph 0195)

NaHCO3    84.0    144-55-8

Action and use

Antacid; used in treatment of electrolyte deficiency.

Preparations

Sodium Bicarbonate Ear Drops

Sodium Bicarbonate Eye Lotion

Sodium Bicarbonate Intravenous Infusion

Sodium Bicarbonate Oral Solution

Compound Sodium Bicarbonate Tablets

Ph Eur

DEFINITION
Content

99.0 per cent to 101.0 per cent.

CHARACTERS
Appearance

White or almost white, crystalline powder.

Solubility

Soluble in water, practically insoluble in ethanol (96 per cent).

When heated in the dry state or in solution, it gradually changes into sodium carbonate.

IDENTIFICATION

A. To 5 mL of solution S (see Tests) add 0.1 mL of phenolphthalein solution R. A pale pink colour is produced. Heat; gas is evolved and the solution becomes red.

B. It gives the reaction of carbonates and bicarbonates (2.3.1).

C. Solution S gives reaction (a) of sodium (2.3.1).

TESTS
Solution S

Dissolve 5.0 g in 90 mL of carbon dioxide-free water R and dilute to 100.0 mL with the same solvent.

Appearance of solution

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

Carbonates

The pH (2.2.3) of freshly prepared solution S is not greater than 8.6.

Maximum 150 ppm.

To 7 mL of solution S add 2 mL of nitric acid R and dilute to 15 mL with water R.

Sulfates (2.4.13)

Maximum 150 ppm.

To a suspension of 1.0 g in 10 mL of distilled water R add hydrochloric acid R until neutral and about 1 mL in excess. Dilute to 15 mL with distilled water R.

Ammonium (2.4.1)

Maximum 20 ppm.

Dilute 10 mL of solution S to 15 mL with water R. Prepare the standard using a mixture of 5 mL of water R and 10 mL of ammonium standard solution (1 ppm NH4) R.

Arsenic (2.4.2, Method A)

Maximum 2 ppm, determined on 0.5 g.

Calcium (2.4.3)

Maximum 100 ppm.

To a suspension of 1.0 g in 10 mL of distilled water R add hydrochloric acid R until neutral and dilute to 15 mL with distilled water R.

Iron (2.4.9)

Maximum 20 ppm.

Dissolve 0.5 g in 5 mL of dilute hydrochloric acid R and dilute to 10 mL with water R.

Maximum 10 ppm.

Dissolve 2.0 g in a mixture of 2 mL of hydrochloric acid R and 18 mL of water R. 12 mL of the solution complies with test A. Prepare the reference solution using lead standard solution (1 ppm Pb) R.

ASSAY

Dissolve 1.500 g in 50 mL of carbon dioxide-free water R. Titrate with 1 M hydrochloric acid, using 0.2 mL of methyl orange solution R as indicator.

1 mL of 1 M hydrochloric acid is equivalent to 84.0 mg of NaHCO3.

Ph Eur