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6.1.12.aluminium Sulfate (Aluminii Sulfas)

The document provides detailed specifications for Aluminium sulfate (Aluminii sulfas), including its chemical composition, physical properties, solubility, and storage requirements. It outlines identity tests, limits for heavy metals, ammonium salts, iron, and alkali and alkaline-earth metals, as well as pH and assay methods. The document is part of the International Pharmacopoeia - Eleventh Edition, 2022.

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5 views1 page

6.1.12.aluminium Sulfate (Aluminii Sulfas)

The document provides detailed specifications for Aluminium sulfate (Aluminii sulfas), including its chemical composition, physical properties, solubility, and storage requirements. It outlines identity tests, limits for heavy metals, ammonium salts, iron, and alkali and alkaline-earth metals, as well as pH and assay methods. The document is part of the International Pharmacopoeia - Eleventh Edition, 2022.

Uploaded by

Subhash Chandra Bose Kotte
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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The International Pharmacopoeia - Eleventh Edition, 2022 Aluminium sulfate (Aluminii sulfas)

Aluminium sulfate (Aluminii sulfas)


Al2(SO4)3,nH2O

Relative molecular mass. 342.1 (anhydrous).

Chemical name. Aluminium sulfate (2:3); CAS Reg. No. 10043-01-3 (anhydrous). Aluminium sulfate (2:3) hydrate; CAS Reg. No.
17927-65-0 (hydrate).

Description. Colourless, lustrous crystals or crystalline masses, or a white, crystalline powder; odourless.

Solubility. Soluble in cold water; freely soluble in hot water; practically insoluble in ethanol (~750 g/l) TS.

Category. Astringent drug; used in the preparation of aluminium acetate solution.

Storage. Aluminium sulfate should be kept in a well-closed container.

Aluminium sulfate contains a variable quantity of water of crystallization.

Requirements

Aluminium sulfate contains not less than 51.0% and not more than the equivalent of 59.0% of Al2(SO4)3.

Identity tests

A. Dissolve 0.2 g in 2 mL of water and add 0.5 mL of hydrochloric acid (~70 g/l) TS and 0.5 mL of alkaline
thioacetamide TS; no precipitate is formed. Add drop by drop sodium hydroxide (~80 g/l) TS; a white, gelatinous
precipitate is formed which dissolves on further addition of sodium hydroxide. Gradually add ammonium chloride
(100 g/l) TS; a white, gelatinous precipitate reappears.

B. A 0.1 g/mL solution yields reaction A described under 2.1 General identification tests as characteristic of
sulfates.

Heavy metals. Use 1.0 g for the preparation of the test solution as described under 2.2.3 Limit test for heavy metals, Procedure 1;
determine the heavy metals content according to Method A; not more than 50 μg/g.

Ammonium salts. Heat 1 g with 10 mL of sodium hydroxide (1 mol/l) VS on a water-bath for 1 minute; no odour of ammonia is
perceptible.

Iron. Use 0.4 g; the solution complies with the 2.2.4 Limit test for iron; not more than 100 μg/g.

Alkali and alkaline-earth metals. Dissolve 1.0 g in 100 mL of water, heat, and add 0.1 mL of methyl red/ethanol TS and sufficient
ammonia (~100 g/l) TS until the colour of the solution changes to yellow. Dilute to 150 mL with water, heat to boiling, and filter.
Evaporate 75 mL of the filtrate to dryness on a water-bath and ignite to constant mass; the residue weighs not more than 2 mg
(0.4%).

Colour and clarity of solution. A solution of 0.50 g in 10 mL of water is colourless and not more opalescent than opalescence
standard TS2.

pH value. pH of a 20 mg/mL solution in carbon-dioxide-free water R, 2.5-4.0.

Assay. Dissolve about 0.5 g, accurately weighed, in 20 mL of water, and proceed as described under 2.5 Complexometric
titrations for aluminium.

Each mL of disodium edetate (0.05 mol/l) VS is equivalent to 8.554 mg of Al2(SO4)3.

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