Aluminum Zirconium Octachlorohydrex Gly Solution
»Aluminum Zirconium Octachlorohydrex Gly Solution is a solution of Aluminum Zirconium Octachlorohydrate in which some of the waters of hydration have been displaced by glycine,calcium glycinate,magnesium glycinate,potassium glycinate,sodium glycinate,or zinc glycinate.It encompasses a range of aluminum-to-zirconium ratios between 6.0:1and 10.0:1,and a range of (aluminum plus zirconium)-to-chloride atomic ratios between 1.5:1and 0.9:1.The following solvents may be used:water,propylene glycol,or dipropylene glycol.It contains the equivalent of not less than 90.0percent and not more than 110.0percent of the labeled concentration of anhydrous aluminum zirconium octachlorohydrate.
Packaging and storage— Preserve in well-closed containers.
Labeling— Label Solution to state the solvent and form of glycine used and the claimed concentration of anhydrous aluminum zirconium octachlorohydrate.
Identification—
A: Asolution containing the equivalent of about 100mg of anhydrous aluminum zirconium octachlorohydrate per mLresponds to the test for Chloride á191ñ.
B:Identification of propylene glycol(where stated on the label)— Add about 10mLof isopropyl alcohol to 2g of Solution,mix,and filter.Evaporate the filtrate to about 1mLon a steam bath:the IRabsorption spectrum of a film of this solution on a silver chloride disk exhibits maxima only at the same wavelengths as that of a similar preparation of a film of propylene glycol.
C:Identification of dipropylene glycol(where stated on the label)— Add about 10mLof isopropyl alcohol to 2g of Solution,mix,and filter.Evaporate the filtrate to about 1mLon a steam bath:the IRabsorption spectrum of a film of this solution on a silver chloride disk exhibits maxima only at the same wavelengths as that of a similar preparation of a film of dipropylene glycol.
D:Identification of glycine— Place about 1g of Solution in a 50-mLbeaker,add about 20mLof water,and swirl to dissolve.Heat to boiling on a hot plate,and add about 60mg of ninhydrin:a deep violet color immediately develops.
pHá791ñ: between 3.0and 5.0,in a solution prepared by diluting 3g of the Solution with water to obtain 10mL.
Arsenic,Method Iá211ñ— Prepare the Test Preparationusing an accurately weighed quantity of the Solution.The limit is 2µg per g.
Heavy metals,Method Iá231ñ— Proceed as directed in the chapter,except to use the following modifications.
Test Preparation— Prepare as directed in the chapter,using an accurately weighed quantity of Solution.If the solution is not clear after dilution to 40mL,heat for several minutes between 60and 80,and cool to room temperature.If the solution remains cloudy,repeat from the beginning with the following modification:add 3mLof hydrochloric acid prior to adjustment of the pHwith 6Nammonium hydroxide.
Monitor Preparation— Prepare as directed in the chapter,using the same modifications described for Test Preparationif necessary.
Procedure— To each of the three tubes containing the Standard Preparation,the Test Preparation,and the Monitor Preparation,add 2mLof pH3.5Acetate Buffer,and heat gently to between 60and 80.To the Standard Preparationadd 6drops of sodium sulfide TS.To the Test Preparationand the Monitor Preparationadd 12drops of sodium sulfide TS.Cool to room temperature,and dilute the contents of each tube with water to 50mL.Gently mix each tube by inverting twice.Allow to stand for 5minutes,and view downward over a white surface.The color of the solution from the Test Preparationis not darker than that of the solution from the Standard Preparation,and the color of the solution from the Monitor Preparationis the same as or darker than the color of the solution from the Standard Preparation.If the color of the solution from the Monitor Preparationis lighter than the color of the solution from the Standard Preparation,repeat the procedure with the following modification:after the heating step,to the Monitor Preparationand the Test Preparationadd 1.0mL,instead of 12drops,of sodium sulfide TS.Not more than 10µg per g is found.
Limit of iron— Using about 5.4g of Aluminum Zirconium Octachlorohydrex Gly Solution,accurately weighed,instead of Aluminum Zirconium Octachlorohydrate,proceed as directed in the test for the Limit of ironunder Aluminum Zirconium Octachlorohydrate.The limit is 75µg per g.
Content of aluminum— Using about 0.3g of Aluminum Zirconium Octachlorohydrex Gly Solution instead of Aluminum Zirconium Octachlorohydrate,proceed as directed in the test for the Content of aluminumunder Aluminum Zirconium Octachlorohydrate.Use the result to calculate the Aluminum/zirconium atomic ratioand the (Aluminum plus zirconium)/chloride atomic ratio.
Content of zirconium— Using about 500mg of Aluminum Zirconium Octachlorohydrex Gly Solution,accurately weighed,instead of Aluminum Zirconium Octachlorohydrate,proceed as directed in the test for the Content of zirconiumunder Aluminum Zirconium Octachlorohydrate.Use the result to calculate the Aluminum/zirconium atomic ratioand the (Aluminum plus zirconium)/chloride atomic ratio.
Aluminum/zirconium atomic ratio— Divide the percentage of aluminum found in the test for Content of aluminumby the percentage of zirconium found in the test for Content of zirconium,and multiply by 92.97/26.98,in which 92.97is the atomic weight of zirconium corrected for 2%hafnium content,and 26.98is the atomic weight of aluminum:the ratio is between 6.0:1and 10.0:1.
Content of chloride— Using about 500mg of Aluminum Zirconium Octachlorohydrex Gly Solution,accurately weighed,instead of Aluminum Zirconium Octachlorohydrate,proceed as directed in the test for the Content of chlorideunder Aluminum Zirconium Octachlorohydrate.Use the result to calculate the (Aluminum plus zirconium)/chloride atomic ratio.
(Aluminum plus zirconium)/chloride atomic ratio— Calculate the (aluminum plus zirconium)/chloride atomic ratio by the formula:
[(Al/26.98)+(Zr/92.97)]/(Cl/35.453),
in which Al,Zr,and Clare the percentages of aluminum,zirconium,and chloride found in the tests for Content of aluminum,Content of zirconium,and Content of chloride,respectively;26.98is the atomic weight of aluminum;92.97is the atomic weight of zirconium corrected for 2%hafnium content;and 35.453is the atomic weight of chlorine:the ratio is between 1.5:1and 0.9:1.
Assay— Calculate the percentage of anhydrous aluminum zirconium octachlorohydrate in the Solution by the formula:
Al({26.98y+92.97+17.01[3y+4-(y+1)/z]+35.453(y+1)/z}/26.98y),
in which Alis the percentage of aluminum found in the test for Content of aluminum,yis the aluminum/zirconium atomic ratio found in the test for Aluminum/zirconium atomic ratio,zis the (aluminum plus zirconium)/chloride atomic ratio found in the test for (Aluminum plus zirconium)/chloride atomic ratio,26.98is the atomic weight of aluminum,92.97is the atomic weight of zirconium corrected for 2%hafnium content,17.01is the molecular weight of the hydroxide anion (OH),and 35.453is the atomic weight of chlorine (Cl).
Auxiliary Information— Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(PA6)Pharmaceutical Analysis 6
USP28–NF23Page 100
Pharmacopeial Forum:Volume No.27(4)Page 2693
Phone Number:1-301-816-8389
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