Dihydroxyaluminum Aminoacetate
;)
Aluminum,(glycinato-N,O)dihydroxy-,hydrate.
(Glycinato)dihydroxyaluminum hydrate [41354-48-7].
Anhydrous 135.06 [13682-92-3].
»Dihydroxyaluminum Aminoacetate yields not less than 94.0percent and not more than 102.0percent of dihydroxyaluminum aminoacetate (C2H6AlNO4),calculated on the dried basis.It may contain small amounts of aluminum oxide and of Aminoacetic Acid.
Packaging and storage—
Preserve in well-closed containers.
Identification—
Suspend 1g in 25mLof water,add hydrochloric acid,dropwise,until a clear solution is formed,and divide it into two equal parts for the following tests.
A:
One portion of the solution responds to the tests for Aluminum á191ñ.
B:
To the other portion of the solution add 1drop of liquefied phenol and 5mLof sodium hypochlorite TS:a blue color is produced.
pHá791ñ:
between 6.5and 7.5,in a suspension of 1g of it,finely powdered,in 25mLof water.
Loss on drying á731ñ—
Dry it at 130
to constant weight:it loses not more than 14.5%of its weight.
to constant weight:it loses not more than 14.5%of its weight.
Mercury,Method IIa á261ñ—
Transfer 2.0g to a 100-mLbeaker,and add 35mLof 1Nsulfuric acid:the limit is 1ppm.
Isopropyl alcohol—
Transfer about 5g to a flask provided with a reflux condenser,and add 100mLof potassium permanganate solution (1in 300)and 10mLof sulfuric acid.Reflux the mixture for 30minutes,distill,and collect 10mLof the distillate.To 1mLof the distillate add 5drops of sodium nitroferricyanide TSand 2mLof 1Nsodium hydroxide,then add a slight excess of 6Nacetic acid:no red color is produced.
Nitrogen—
Determine the nitrogen content as directed under Nitrogen Determination,Method IIá461ñ,using about 100mg,previously dried and accurately weighed.Each mLof 0.1Nsulfuric acid is equivalent to 1.401mg of nitrogen.Not less than 9.90%and not more than 10.60%of nitrogen is found.
Organic volatile impurities,Method IVá467ñ:
meets the requirements.
Assay—
Edetate disodium titrant—
Prepare and standardize as directed in the Assayunder Ammonium Alum.
Procedure—
Transfer about 2.5g of Dihydroxyaluminum Aminoacetate,accurately weighed,to a 150-mLbeaker,add 15mLof hydrochloric acid,and warm,if necessary,to dissolve the specimen completely.Transfer the solution with the aid of water to a 500-mLvolumetric flask,dilute with water to volume,and mix.Transfer 20.0mLof this solution to a 250-mLbeaker,and add,with continuous stirring,25.0mLof Edetate disodium titrantand then 20mLof acetic acid-ammonium acetate buffer TS.Heat the solution near the boiling point for 5minutes,cool,and add 50mLof alcohol and 2mLof dithizone TS.Titrate with 0.05Mzinc sulfate VSuntil the color changes from green-violet to rose pink.Perform a blank determination,substituting 20mLof water for the assay solution,and make any necessary correction.Each mLof 0.05M Edetate disodium titrantis equivalent to 6.753mg of C2H6AlNO4.
Auxiliary Information—
Staff Liaison:Elena Gonikberg,Ph.D.,Scientist
Expert Committee:(PA4)Pharmaceutical Analysis 4
USP28–NF23Page 652
Phone Number:1-301-816-8251