Magnesium Aluminosilicate
»Magnesium Aluminosilicate is a synthesized material that contains not less than 20.5percent and not more than 27.7percent of magnesium oxide (MgO),not less than 27.0percent and not more than 34.3percent of aluminum oxide (Al2O3),and not less than 14.4percent and not more than 21.7percent of silicon dioxide (SiO2),calculated on the dried basis.
Packaging and storage— Preserve in tight containers,and prevent exposure to excessive heat.
Acid-consuming capacity— Transfer about 0.2g of Magnesium Aluminosilicate,accurately weighed,to a glass-stoppered flask,and add 100.0mLof 0.1Nhydrochloric acid VS.Stopper the flask tightly,shake at 37±2for 1hour,and filter.Transfer 50.0mLof the filtrate to a beaker,and,while stirring,titrate the excess hydrochloric acid with 0.1Nsodium hydroxide VSto attain a pHof 3.5.Perform a blank determination,and make any necessary correction:not less than 250mLof 0.1Nhydrochloric acid is consumed per g of Magnesium Aluminosilicate,calculated on the dried basis.
pHá791ñ— Transfer 2g of Magnesium Aluminosilicate to a suitable container,and add 50mLof water.While stirring,immerse the pHelectrodes in the suspension,and after 2minutes record the pH:between 8.5and10.5.
Other requirements— It meets the requirements for Identification,Loss on drying,Soluble salts,Alkalinity,Chloride,Sulfate,Arsenic,Iron,and Heavy metalsunder Magnesium Aluminometasilicate.
Assay for aluminum oxide,magnesium oxide,and silicon dioxide— Proceed as directed in the Assay for aluminum oxide,the Assay for magnesium oxide,and the Assay for silicon dioxideunder Magnesium Aluminometasilicate.
Auxiliary Information— Staff Liaison:Catherine Sheehan,B.Sc.,Scientist
Expert Committee:(EMC)Excipients:Monograph Content
USP28–NF23Page 3027
Pharmacopeial Forum:Volume No.28(4)Page 1217
Phone Number:1-301-816-8262