Aluminum Zirconium Trichlorohydrex Gly Solution
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
Aluminum Zirconium Trichlorohydrex Gly Solution is a solution of Aluminum Zirconium Trichlorohydrate 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 2.0:1 and 5.99:1 and a range of (aluminum plus zirconium)-to-chloride atomic ratios between 2.1:1 and 1.51:1. The following solvents may be used: water, propylene glycol, or dipropylene glycol. It contains the equivalent of not less than 90.0 percent and not more than 110.0 percent of the labeled concentration of anhydrous aluminum zirconium trichlorohydrate.
1 Packaging and storage
Preserve in well-closed containers.
2 Labeling
Label Solution to state the solvent and form of glycine used and the claimed concentration of anhydrous aluminum zirconium trichlorohydrate.
3 Identification
A: A solution containing the equivalent of about 100 mg of anhydrous aluminum zirconium trichlorohydrate per mL responds to the test for Chloride 〈191〉.
B: Identification of propylene glycol (where stated on the label)—Add about 10 mL of isopropyl alcohol to 2 g of Solution, mix, and filter.
Evaporate the filtrate to about 1 mL on a steam bath: the IR 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 10 mL of isopropyl alcohol to 2 g of Solution, mix, and filter.
Evaporate the filtrate to about 1 mL on a steam bath: the IR 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 1 g of Solution in a 50-mL beaker, add about 20 mL of water, and swirl to dissolve. Heat to boiling on a hot plate, and add about 60 mg of ninhydrin: a deep violet color immediately develops.
pH 〈791〉: between 3.0 and 5.0, in a solution prepared by diluting 3 g of the Solution with water to obtain 10 mL.
Change to read:
Arsenic 〈211〉, Procedures, Procedure 1 (CN 1-Jun-2023) —Prepare the Test Preparation using an accurately weighed quantity of the Solution.
The limit is 2 μg per g.
Limit of iron - Using about 5.4 g of Aluminum Zirconium Trichlorohydrex Gly Solution, accurately weighed, instead of Aluminum Zirconium
Octachlorohydrate, proceed as directed in the test for the Limit of iron under Aluminum Zirconium Octachlorohydrate. The limit is 75 μg per g.
Content of aluminum - Using about 0.3 g of Aluminum Zirconium Trichlorohydrex Gly Solution instead of Aluminum Zirconium
Octachlorohydrate, proceed as directed in the test for the Content of aluminum under Aluminum Zirconium Octachlorohydrate. Use the result to calculate the Aluminum/zirconium atomic ratio and the (Aluminum plus zirconium)/chloride atomic ratio.
Content of zirconium - Using about 500 mg of Aluminum Zirconium Trichlorohydrex Gly Solution, accurately weighed, instead of Aluminum
Zirconium Octachlorohydrate, proceed as directed in the test for the Content of zirconium under Aluminum Zirconium Octachlorohydrate. Use the result to calculate the Aluminum/zirconium atomic ratio and the (Aluminum plus zirconium)/chloride atomic ratio.
Aluminum/zirconium atomic ratio - Divide the percentage of aluminum found in the test for Content of aluminum by the percentage of zirconium found in the test for Content of zirconium and multiply by 92.97/26.98, in which 92.97 is the atomic weight of zirconium corrected for 2% hafnium content, and 26.98 is the atomic weight of aluminum: the ratio is between 2.0:1 and 5.99:1.
Content of chloride - Using about 500 mg of Aluminum Zirconium Trichlorohydrex Gly Solution, accurately weighed, instead of Aluminum
Zirconium Octachlorohydrate, proceed as directed in the test for the Content of chloride under 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 Cl are the percentages of aluminum, zirconium, and chloride found in the tests for Content of aluminum, Content of zirconium, and Content of chloride, respectively; 26.98 is the atomic weight of aluminum; 92.97 is the atomic weight of zirconium corrected for 2% hafnium content; and 35.453 is the atomic weight of chlorine: the ratio is between 2.1:1 and 1.51:1.
Assay - Calculate the percentage of anhydrous aluminum zirconium trichlorohydrate 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 Al is the percentage of aluminum found in the test for Content of aluminum, y is the aluminum/zirconium atomic ratio, as determined in the test for Aluminum/zirconium atomic ratio, z is the (aluminum plus zirconium)/chloride atomic ratio as determined in the test for (Aluminum plus zirconium)/chloride atomic ratio, 26.98 is the atomic weight of aluminum, 92.97 is the atomic weight of zirconium corrected for 2% hafnium content, 17.01 is the molecular weight of the hydroxide anion (OH), and 35.453 is the atomic weight of chlorine (Cl).
