Aluminium Glycnate

Aluminium Glycinate BP Ph Eur Grade Specifications
C2H6AlNO4-xH2O --- 135.1 --- CAS 41354-48-7
Action and use: Antacid.

DEFINITION
Aluminium Glycinate is a basic aluminium monoglycinate, partly hydrated. It contains not less than 34.5% and not more than 38.5% of Al2O3 and not less than 9.9% and not more than 10.8% of N, both calculated with reference to the dried substance.

CHARACTERISTICS
A white or almost white powder.
Practically insoluble in water and in organic solvents. It dissolves in dilute mineral acids and in aqueous solutions of the alkali hydroxides.

IDENTIFICATION
A. Add 0.1 g to 10 ml of a solution prepared by dissolving 0.84 g of citric acid in 8 ml of 1M sodium hydroxide and diluting to 20 ml with water. Add 0.5 ml of a 0.1% w/v solution of ninhydrin in methanol and warm. A purple colour is produced.
B. Suspend 1 g in 25 ml of 0.5M hydrochloric acid and heat gently until a clear solution is produced. Reserve half of the solution. To 2 ml of the solution add 0.15 ml of liquefied phenol , shake and add carefully without shaking 5 ml of dilute sodium hypochlorite solution. A blue colour is produced.
C. The solution reserved in test B yields the reaction characteristic of aluminium salts.

TESTS
Acidity or alkalinity: pH of a suspension of 1 g in 25 ml of carbon dioxide-free water, 6.5 to 7.5.
Neutralising capacity: Shake 0.2 g vigorously with 25 ml of 0.1M hydrochloric acid for 5 minutes and allow to stand for 5 minutes. The pH of the mixture is greater than 3.0.
Arsenic: Dissolve 2.0 g in 18 ml of brominated hydrochloric acid and 32 ml of water. 25 ml of the resulting solution complies with the limit test for arsenic, 1 ppm.
Heavy metals: Dissolve 1.5 g in 20 ml of 2M hydrochloric acid and 10 ml of water, add 0.5 ml of nitric acid and boil for about 30 seconds. Cool, add 2 g of ammonium chloride and 2 g of ammonium thiocyanate and extract with two 10 ml quantities of a mixture of equal parts of isoamyl alcohol and ether . To the aqueous layer add 2 g of citric acid. 12 ml of the resulting solution complies with limit test A for heavy metals, Appendix VII. Use lead standard solution (1 ppm Pb) to prepare the standard (20 ppm).
Mercuric salts: To pass the test.
Chloride: Dissolve 1.0 g in 10 ml of 2M nitric acid and dilute to 100 ml with water. 15 ml of the resulting solution complies with the limit test for chlorides, Appendix VII (330 ppm).
Loss on drying: When dried to constant weight at 130C, loses not more than 12.0% of its weight. Use 1 g.

ASSAY
For Al2O3: Dissolve 0.25 g in a mixture of 3 ml of 1M hydrochloric acid and 50 ml of water, add 50 ml of 0.05M disodium edetate and neutralise with 1M sodium hydroxide using methyl red solution as indicator. Heat the solution to boiling, allow to stand for 10 minutes on a water bath, cool rapidly, add about 50 mg of xylenol orange triturate and 5 g of hexamine and titrate the excess of disodium edetate with 0.05M lead nitrate until the solution becomes red.
Each ml of 0.05M disodium edetate VS is equivalent to 2.549 mg of Al2O3.

Dihydroxyaluminum Aminoacetate USP Grade Specifications
C2H6AlNO4-xH2O
Aluminum, (glycinato-N,O)dihydroxy-, hydrate.
(Glycinato)dihydroxyaluminum hydrate [CAS 41354-48-7].
Anhydrous 135.06 [CAS 13682-92-3].

Dihydroxyaluminum Aminoacetate yields not less than 94.0 percent and not more than 102.0 percent of dihydroxyaluminum aminoacetate (C2H6AlNO4), calculated on the dried basis. It may contain small amounts of aluminum oxide and of Aminoacetic Acid.

Certifications :
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