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 95.0percent and not more than 105.0percent of the labeled amount of Gold Sodium Thiomalate.
Packaging and storage— Preserve in single-dose or multiple-dose containers,preferably of Type Iglass,and store protected from light.
Identification— It responds to Identificationtests Aand Bunder Gold Sodium Thiomalate.
pHá791ñ: between 5.8and 6.5.
Other requirements— It meets the requirements under Injections á1ñ.
Assay— Transfer an accurately measured volume of Injection,equivalent to about 500mg of gold sodium thiomalate,to a 300-mL Kjeldahl flask,and proceed as directed in the Assayunder Gold Sodium Thiomalate,beginning with “add 20mLof 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— Staff Liaison:Clydewyn M.Anthony,Ph.D.,Scientist
Expert Committee:(PA2)Pharmaceutical Analysis 2
USP28–NF23Page 916
Phone Number:1-301-816-8139
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