Gold Sodium Thiomalate Injection

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Gold Sodium Thiomalate Injection

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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)

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Gold Sodium Thiomalate Injection is a sterile solution of Gold Sodium Thiomalate in Water for Injection. It contains not less than 95.0 percent and not more than 105.0 percent of the labeled amount of Gold Sodium Thiomalate.

Packaging and storage—Preserve in single-dose or multiple-dose containers, preferably of Type I glass, and store protected from light.

Identication—It responds to Identification tests A and B under Gold Sodium Thiomalate.

pH 〈791〉: between 5.8 and 6.5.

Other requirements—It meets the requirements under Injections and Implanted Drug Products 〈1〉.

Assay—Transfer an accurately measured volume of Injection, equivalent to about 500 mg of gold sodium thiomalate, to a 300-mL Kjeldahl ask, and proceed as directed in the Assay under Gold Sodium Thiomalate, beginning with “add 20 mL of nitric acid.” The weight of the gold so obtained, multiplied by 2.116, represents the weight of Gold Sodium Thiomalate in the portion of Injection taken.

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