Gallamine Triethiodide Injection
»Gallamine Triethiodide Injection is a sterile solution of Gallamine Triethiodide in Water for Injection.It contains not less than 95.0percent and not more than 105.0percent of the labeled amount of gallamine triethiodide (C30H60I3N3O3).
Packaging and storage— Preserve in single-dose or multiple-dose containers,preferably of Type Iglass,protected from light.
Identification— Evaporate a volume of Injection,equivalent to not less than 200mg of gallamine triethiodide,to dryness.Take up the residue in warm alcohol,and pass through fine filter paper.Remove a portion of the filtrate,equivalent to about 100mg of gallamine triethiodide,and evaporate to dryness:the residue responds to the Identificationtests under Gallamine Triethiodide.
Bacterial endotoxins á85ñ— It contains not more than 5.0USP Endotoxin Units per mg of gallamine triethiodide.
pHá791ñ: between 6.5and 7.5.
Other requirements— It meets the requirements under Injections á1ñ.
Assay—
Sodium perchlorate buffer,Mobile phase,Standard preparation,and Chromatographic system— Proceed as directed in the Assayunder Gallamine Triethiodide.
Assay preparation— Transfer an accurately measured volume of Injection,equivalent to about 100mg of gallamine triethiodide,to a 100-mLvolumetric flask,dissolve in and dilute with Mobile phaseto volume,and mix.
Procedure— Separately inject equal volumes (about 10µL)of the Standard preparationand the Assay preparationinto the chromatograph,record the chromatograms,and measure the responses for the major peaks.Calculate the quantity,in mg,of C30H60I3N3O3in the portion of Injection taken by the formula:
100C(rU/rS),
in which Cis the concentration,in mg per mL,of USP Gallamine Triethiodide RSin the Standard preparation,and rUand rSare the peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 888
Phone Number:1-301-816-8379