Aluminium Magnesium Silicate

Aluminium Magnesium Silicate BP Grade & Ph Eur
Ph Eur
12511-31-8
Action and use: Excipient.

DEFINITION
Mixture of particles with colloidal particle size of montmorillonite and saponite, free from grit and non-swellable ore.
Content:
aluminium (Al; Ar 26.98): 95.0 per cent to 105.0 per cent of the value stated on the label.
magnesium (Mg; Ar 24.30): 95.0 per cent to 105.0 per cent of the value stated on the label.

CHARACTERS
Appearance: Almost white powder, granules or plates.
Solubility: Practically insoluble in water and in organic solvents. It swells in water to produce a colloidal dispersion.

IDENTIFICATION
A. Fuse 1 g with 2 g of anhydrous sodium carbonate. Warm the residue with water and filter. Acidify the filtrate with hydrochloric acid and evaporate to dryness on a water-bath. 0.25 g of the residue gives the reaction of silicates.
B. Dissolve the remainder of the residue obtained in identification test A in a mixture of 5 mL of dilute hydrochloric acid and 10 mL of water. Filter and add ammonium chloride buffer solution pH 10.0. A white, gelatinous precipitate is formed. Centrifuge and keep the supernatant for identification C. Dissolve the remaining precipitate in dilute hydrochloric acid. The solution gives the reaction of aluminium.
C. The supernatant liquid obtained after centrifugation in identification test B gives the reaction of magnesium.

TESTS
pH: 9.0 to 10.0.
Disperse 5.0 g in 100 mL of carbon dioxide-free water.
Arsenic: Maximum 3 ppm.
Transfer 16.6 g to a 250 mL beaker containing 100 mL of dilute hydrochloric acid. Mix, cover with a watch glass and boil gently, with occasional stirring, for 15 min. Allow the insoluble matter to settle and decant the supernatant liquid through a rapid- flow filter paper into a 250 mL volumetric flask, retaining as much sediment as possible in the beaker. To the residue in the beaker add 25 mL of hot dilute hydrochloric acid, stir, heat to boiling, allow the insoluble matter to settle and decant the supernatant liquid through the filter into the volumetric flask. Repeat the extraction with 4 additional quantities, each of 25 mL, of hot dilute hydrochloric acid, decanting each supernatant liquid through the filter into the volumetric flask. At the last extraction, transfer as much of the insoluble matter as possible onto the filter. Allow the combined filtrates to cool to room temperature and dilute to 250.0 mL with dilute hydrochloric acid. Dilute 5.0 mL of this solution to 25.0 mL with dilute hydrochloric acid.
Lead: Maximum 15 ppm.
Loss on drying: Maximum 8.0 per cent, determined on 1.000 g by drying in an oven at 105C.
Microbial contamination:
TAMC: acceptance criterion 1000 CFU/g.
TYMC: acceptance criterion 100 CFU/g.
Absence of Escherichia coli.

LABELLING
The label states the content of aluminium and magnesium.

We also offer Magnesium Aluminium Silicate USP NF Grade

Certifications :
We manufacture Bulk Drugs / API, Excipients, Pharmaceuticals (IP/BP/USP/NF/Ph. Eur, JP/ CP), Speciality Chemicals(Pure/AR/ACS), Mineral Fortifiers, Food Chemical Codex (FCC) and Flavour chemicals. Our manufacturing facility is cGMP, GLP, ISO 9001, ISO 14001, ISO 22000, ISO/IEC 17025, FSSC 22000, FSSAI, Kosher, HALAL, EXCiPACT, WC, COPP, WHO-GMP and WC certified. We are also REACH registered for export to European countries.