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Magaldrate
CAS Number: 74978-16-8
Molecular Formula: Al5Mg10(OH)31(SO4)2-xH2O
Molecular Weight: 1097.38
Magaldrate
Specifications of Magaldrate USP Grade:
Aluminum magnesium hydroxide sulfate --- Al5Mg10(OH)31(SO4)2-xH2O.
Aluminum magnesium hydroxide sulfate, hydrate --- CAS 74978-16-8.
Anhydrous --- 1097.38
Magaldrate is a chemical combination of aluminum and magnesium hydroxides and sulfate, corresponding approximately to the formula: Al5Mg10(OH)31(SO4)2-xH2O. It contains the equivalent of not less than 90.0 percent and not more than 105.0 percent of Al5Mg10(OH)31(SO4)2, calculated on the dried basis.
Identification:
A: Dissolve about 600 mg in 20 mL of 3 N hydrochloric acid, add 3 drops of methyl red and about 30 mL of water, and heat to boiling. Add 6 N ammonium hydroxide until the color just changes to yellow, continue boiling for 2 minutes, and filter: the filtrate responds to the tests for Magnesium.
B: Wash the precipitate obtained in Identification test A with 50 mL of hot ammonium chloride solution (1 in 50), then dissolve the precipitate in 15 mL of 3 N hydrochloric acid: the solution responds to the tests for Aluminum.
C: Its X-ray diffraction pattern in the d-spacings region below 0.257 nm (2.57 angstrom units) conforms to that of USP Magaldrate.
Microbial limits: It meets the requirements of the test for absence of Escherichia coli.
Loss on drying: Dry it at 200 for 4 hours: it loses between 10.0% and 20.0% of its weight.
Soluble chloride: Boil 1 g of it, accurately weighed, with 50.0 mL of water for 5 minutes, cool add water to restore the original volume, mix, and filter. To 25.0 mL of the filtrate add 0.1 mL of potassium chromate and titrate with 0.10 N silver nitrate until a persistent pink color is obtained: not more than 5.0 mL of 0.10 N silver nitrate is required (3.5%).
Soluble sulfate: A 2.5-mL portion of the filtrate obtained in the test for Soluble chloride shows no more sulfate than corresponds to 1.0 mL of 0.020 N sulfuric acid (1.9%).
Sodium: Transfer 2 g of it, accurately weighed, to a 100-mL volumetric flask, place in an ice bath, add 5 mL of nitric acid and swirl to dissolve. Allow to warm to room temperature, dilute with water to volume and mix. Filter, if necessary, to obtain a clear solution. Dilute 10.0 mL of the filtrate with water to 100.0 mL: the emission intensity of this solution, determined with a suitable flame photometer at 589 nm and corrected for background transmission at 580 nm, is not greater than that produced by a standard containing 2.2 micro-g of Na per mL, similarly measured (0.11%).
Arsenic: 8 ppm.
Heavy metals: Dissolve 330 mg in 10 mL of 3 N hydrochloric acid, filter if necessary, to obtain a clear solution and dilute with water to 25 mL: the limit is 0.006%.
Magnesium hydroxide content: To pass the test. --- between 49.2% and 66.6% of Mg(OH)2 is found, calculated on the dried basis.
Aluminum hydroxide content: To pass the test. --- between 32.1% and 45.9% of Al(OH)3 is found, calculated on the dried basis.
Sulfate content: To pass the test. --- between 16.0% and 21.0% of SO4 is found, calculated on the dried basis.
Specifications of Magaldrate BP Ph Eur Grade:
Al5Mg10(OH)31(SO4)2,xH2O --- 1097 --- CAS 74978-16-8 (anhydrous substance)
Action and use: Antacid.
DEFINITION
Magaldrate is composed of aluminium and magnesium hydroxides and sulfates. Its composition corresponds approximately to the formula Al5Mg10(OH)31(SO4)2,xH2O.
Content: 90.0 per cent to 105.0 per cent (dried substance). It contains a variable quantity of water.
CHARACTERS
Appearance: White or almost white, crystalline powder.
Solubility: Practically insoluble in water and in ethanol (96 per cent). It is soluble in dilute mineral acids.
IDENTIFICATION
A. Dissolve 0.6 g in 20 mL of 3 M hydrochloric acid, add about 30 mL of ;water and heat to boiling. Adjust to pH 6.2 with dilute ammonia, continue boiling for a further 2 min, filter and retain the precipitate and the filtrate. To 2 mL of the filtrate add 2 mL of ammonium chloride solution and neutralise with a solution prepared by dissolving 2 g of ammonium carbonate and 2 mL of dilute ammonia in 20 mL of water; no precipitate is produced. Add disodium hydrogen phosphate solution; a white, crystalline precipitate is produced which does not dissolve in dilute ammonia.
B. The precipitate retained in identification test A gives the reaction of aluminium.
C. The filtrate retained in identification test A gives& reaction (a) of sulfates.
TESTS
Soluble chlorides: Maximum 3.5 per cent.
To 0.5 g add 25 mL of dilute nitric acid and shake until completely dissolved. Add 10.0 mL of 0.1 M silver nitrate and 2 mL of ferric ammonium sulfate solution as indicator. Titrate with 0.1 M ammonium thiocyanate, shaking vigorously until a persistent brownish-red colour is obtained.
1 mL of 0.1 M silver nitrate is equivalent to 3.545 mg of Cl.
Soluble sulfates: Maximum 1.9 per cent.
Disperse 0.5 g in 25 ;mL of water, boil for 5 min, cool, dilute to 25.0 mL with water, mix and filter. To 2.5 mL of the filtrate, add 30 mL of water, neutralise to blue litmus paper with hydrochloric acid, add 3 mL of 1 M hydrochloric acid, 3 mL of a 120 g/L solution of barium chloride and dilute to 50 mL with water. Mix and allow to stand for 10 min. Any opalescence in the solution is not more intense than that in a standard prepared at the same time in the same manner using 1& mL of 0.01 M& sulfuric acid ;instead of 2.5 mL of filtrate.
Sulfates: 16.0 per cent to 21.0 per cent (dried substance).
Aluminium hydroxide: 32.1 per cent to 45.9 per cent (dried substance).
Magnesium hydroxide: 49.2 per cent to 66.6 per cent (dried substance).
Sodium: Maximum 0.10 per cent.
Atomic absorption spectrometry: To pass the test.
Loss on drying: 10.0 per cent to 20.0 per cent, determined on 1.000 g by drying in an oven at 200C for 4 h.
Please visit SDS Safety Data Sheet of Magaldrate Suppliers.
American Molecules, also known as ammol.org is a distributor, supplier and manufacturers' representative of all types of Pharmaceuticals, Functional Ingredients, Excipients and Specialty Chemicals in Texas USA. Our principals manufacture supply and export USP NF BP, Ph Eur, etc grades of chemicals pure and reagent grade, mineral fortifiers, FCC food grade. Tailor made particle size and customized specifications are offered. The principal's facility is having one or more of the certifications like FDA approval and GLP, cGMP, ISO9001, ISO14001, ISO/IEC 17025, ISO22000, FSSC 22000, ISO45001, FSSAI, Kosher, HALAL, COPP, WHO-GMP certified and Written Confirmation (WC) for export to Europe is available. The manufacturers suppliers and exporters observe WHO Good Manufacturing Practices and Good Laboratory Practices.
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