Preparations. Action and useHypnotic

Glucose

Chloral Hydrate

C2H3Cl3O2 165.4

Action and use Hypnotic.

DEFINITION

Chloral hydrate contains not less than 98.5 per cent and not more than the equivalent of 101.0 per

cent of 2,2,2-trichloroethane-1,1-diol.

CHARACTERS

Colourless, transparent crystals, very soluble in water, freely soluble in alcohol and in ether.

IDENTIFICATION

A. To 10 ml of solution S (see Tests) add 2 ml of dilute sodium hydroxide solution R. The mixture

becomes cloudy and, when heated, gives off an odour of chloroform.

B. To 1 ml of solution S add 2 ml of sodium sulphide solution R. A yellow colour develops which

quickly becomes reddish-brown. On standing for a short time, a red precipitate may be formed.

TESTS

Solution S Dissolve 3.0 g in carbon dioxide-free water R and dilute to 30 ml with the same solvent.

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

pH (2.2.3). The pH of solution S is 3.5 to 5.5.

Chloral alcoholate Warm 1.0 g with 10 ml of dilute sodium hydroxide solution R, filter the supernatant solution and add 0.05M iodine dropwise until a yellow colour is obtained. Allow to stand for 1 h. No precipitate is formed.

Chlorides (2.4.4). 5 ml of solution S diluted to 15 ml with water R complies with the limit test for

chlorides (100 ppm).

Heavy metals (2.4.8). 10 ml of solution S diluted to 20 ml with water R complies with limit test A

for heavy metals (20 ppm). Prepare the standard using lead standard solution (1 ppm Pb) R.

Non-volatile residue Evaporate 2.000 g on a water-bath. The residue weighs not more than 2 mg

(0.1 per cent).

ASSAY

Dissolve 4.000 g in 10 ml of water R and add 40.0 ml of 1M sodium hydroxide. Allow to stand for

exactly 2 min and titrate with 0.5M sulphuric acid, using 0.1 ml of phenolphthalein solution R as

indicator. Titrate the neutralised solution with 0.1M silver nitrate, using 0.2 ml of potassium chromate solution R as indicator. Calculate the number of millilitres of 1M sodium hydroxide used by deducting from the volume of 1M sodium hydroxide added at the beginning of the titration the volume of 0.5M sulphuric acid used in the first titration and two-fifteenths of the volume of 0.1M silver nitrate used in the second titration.

1 ml of 1M sodium hydroxide is equivalent to 0.1654 g of C2H3Cl3O2.

STORAGE

Store in an airtight container.

C6H12O6,H2O 198.2

Glucose Intravenous Infusion

Glucose Irrigation Solution

Oral Rehydration Salts

Potassium Chloride and Glucose Intravenous Infusion

Potassium Chloride, Sodium Chloride and Glucose Intravenous Infusion

Sodium Chloride and Glucose Intravenous Infusion

DEFINITION

Glucose monohydrate is the monohydrate of D-(+)-glucopyranose.

CHARACTERS

It has the characters described in the monograph Glucose, anhydrous (177).

IDENTIFICATION

It complies with the identification tests prescribed in the monograph Glucose, anhydrous (177).

TESTS

It complies with the tests prescribed in the monograph Glucose, anhydrous (177) with the following

modification:

Water (2.5.12). 7.0 per cent to 9.5 per cent, determined on 0.50 g by the semi-micro determination

of water.

Pyrogens (2.6.8). If intended for use in large-volume preparations for parenteral use, the competent

authority may require that it comply with the test for pyrogens carried out as follows. Inject per

kilogram of the rabbit’s mass 10 ml of a solution containing 55 mg per millilitre of the substance to

be examined in water for injections R.

STORAGE

Store in a well-closed container.

LABELLING

The label states where applicable, that the substance is apyrogenic.

Дата добавления: 2014-12-26