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USP 38 Official Monographs / Aluminum 2137

Content of aluminum—Using Aluminum Dichlorohydrex 0.1 mL of potassium chromate TS and 25 mL of water. Stir,
Propylene Glycol instead of Aluminum Chlorohydrate, pro- and add 0.10 N silver nitrate until a faint, persistent pink
ceed as directed in the test for Content of aluminum under color is obtained: not more than 8.0 mL of 0.10 N silver
Aluminum Chlorohydrate. Use the result obtained to calculate nitrate is required [4.7%, based on the Al(OH)3 content].
the Aluminum/chloride atomic ratio. Sulfate 〈221〉—Add 5.0 mL of 3 N hydrochloric acid to an
Content of chloride—Using Aluminum Dichlorohydrex accurately measured quantity of the Gel, equivalent to 0.3 g
Propylene Glycol instead of Aluminum Chlorohydrate, pro- of Al(OH)3, and heat to dissolve the specimen under test.
ceed as directed in the test for Content of chloride under Cool, dilute with water to 250 mL, and filter if necessary: a
Aluminum Chlorohydrate. Use the result obtained to calculate 20-mL portion of the filtrate shows no more sulfate than
the Aluminum/chloride atomic ratio. corresponds to 0.20 mL of 0.020 N sulfuric acid [0.8%,
Aluminum/chloride atomic ratio—Divide the percent- based on the Al(OH)3 content].
age of aluminum found in the test for Content of aluminum Arsenic, Method I 〈211〉—Prepare a Standard Preparation as
by the percentage of chloride found in the test for Content directed in the test for Arsenic 〈211〉, except to prepare it to
of chloride, and multiply by 35.453/26.98, in which 35.453 contain 5 µg of arsenic instead of 3 µg. Prepare the Test
and 26.98 are the atomic weights of chlorine and alumi- Preparation as follows. Dissolve an accurately measured
num, respectively: the ratio is between 0.90:1 and 1.25:1. quantity of the Gel, equivalent to 0.5 g of Al(OH)3, in 20 mL
Assay—Calculate the percentage of anhydrous aluminum of 7 N sulfuric acid. The limit is 0.001%, based on the
dichlorohydrate in the Aluminum Dichlorohydrex Propylene Al(OH)3 content.
Glycol by the formula:
Al({26.98x + [17.01(3x − 1)] + 35.453} / 26.98x) Delete the following:

in which Al is the percentage of aluminum found in the test •Heavy metals 〈231〉—Dissolve an accurately measured
.

for Content of aluminum, x is the aluminum-to-chloride quantity of the Gel, equivalent to 0.24 g of Al(OH)3, in
atomic ratio, 26.98 is the atomic weight of aluminum, 10 mL of 3 N hydrochloric acid with the aid of heat, filter, if
17.01 is the molecular weight of the hydroxide anion (OH), necessary, and dilute with water to 25 mL: the limit is
and 35.453 is the atomic weight of chlorine (Cl). 0.0083%, based on the Al(OH)3 content.• (Official 1-Dec-2015)
Assay—
Edetate disodium titrant—Prepare and standardize as di-
rected in the Assay under Ammonium Alum.
Procedure—Transfer an accurately measured quantity of
Aluminum Hydroxide Gel
.

Gel, equivalent to about 1.5 g of Al(OH)3, to a beaker, add


Al(OH)3 78.00 15 mL of hydrochloric acid, and heat gently until solution is
Aluminum hydroxide. complete. Cool, transfer to a 500-mL volumetric flask, dilute
Aluminum hydroxide [21645-51-2]. with water to volume, and mix. Pipet 20 mL of this solution
into a 250-mL beaker, and add, in the order named and
» Aluminum Hydroxide Gel is a suspension of with continuous stirring, 25.0 mL of Edetate disodium titrant

USP Monographs
amorphous aluminum hydroxide in which there and 20 mL of acetic acid–ammonium acetate buffer TS, then
heat the solution near the boiling point for 5 minutes. Cool,
is a partial substitution of carbonate for hydrox- and add 50 mL of alcohol and 2 mL of dithizone TS. Titrate
ide. It contains the equivalent of not less than the solution with 0.05 M zinc sulfate VS until the color
90.0 percent and not more than 110.0 percent of changes from green-violet to rose-pink. Perform a blank de-
the labeled amount of aluminum hydroxide termination, substituting 20 mL of water for the sample, and
make any necessary correction. Each mL of 0.05 M Edetate
[Al(OH)3]. It may contain Peppermint Oil, Glyc- disodium titrant consumed is equivalent to 3.900 mg of
erin, Sorbitol, Sucrose, Saccharin, or other suita- Al(OH)3.
ble flavors, and it may contain suitable antimicro-
bial agents.
Packaging and storage—Preserve in tight containers, and
avoid freezing. Dried Aluminum Hydroxide Gel
.

Identification—
Al(OH)3 78.00
A: Place about 1 g in a flask equipped with a stopper and Aluminum hydroxide [21645-51-2].
glass tubing, the tip of which is immersed in calcium hy-
droxide TS in a test tube. Add 5 mL of 3 N hydrochloric » Dried Aluminum Hydroxide Gel is an amor-
acid to the flask, and immediately insert the stopper: gas phous form of aluminum hydroxide in which
evolves in the flask and a precipitate is formed in the test
tube. there is a partial substitution of carbonate for hy-
B: The solution remaining in the flask responds to the droxide. It contains the equivalent of not less
tests for Aluminum 〈191〉. than 76.5 percent of Al(OH)3, and it may contain
Microbial enumeration tests 〈61〉 and Tests for speci- varying quantities of basic aluminum carbonate
fied microorganisms 〈62〉—Its total aerobic microbial and bicarbonate.
count does not exceed 100 cfu per mL, and it meets the
requirements of the test for the absence of Escherichia coli. Packaging and storage—Preserve in tight containers.
Acid-neutralizing capacity 〈301〉—Not less than 65.0% Labeling—Where the quantity of dried aluminum hydrox-
of the expected mEq value, calculated from the results of ide gel equivalent is stated in the labeling of any prepara-
the Assay, is obtained. Each mg of Al(OH)3 has an expected tion, this shall be understood to be on the basis that each
acid-neutralizing capacity value of 0.0385 mEq. mg of dried gel is equivalent to 0.765 mg of Al(OH)3.
pH 〈791〉: between 5.5 and 8.0, determined potentiomet- USP Reference standards 〈11〉—
rically. USP Dried Aluminum Hydroxide Gel RS
Chloride—Transfer an accurately measured quantity of the
Gel, equivalent to 0.6 g of Al(OH)3, to a porcelain dish. Add

Official from August 1, 2015


Copyright (c) 2015 The United States Pharmacopeial Convention. All rights reserved.

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