Gold Sodium Thiomalate Injection
» 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.
Identification— 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 1.
Assay— Transfer an accurately measured volume of Injection, equivalent to about 500 mg of gold sodium thiomalate, to a 300-mL Kjeldahl flask, 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.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Clydewyn M. Anthony, Ph.D.
Senior Scientific Liaison
(SM22010) Monographs - Small Molecules 2
USP35–NF30 Page 3361