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Kit for the Preparation of Technetium Tc99m Bicisate for Injection FOR DIAGNOSTIC USE


This kit formulation consists of two nonradioactive vials: Vial A contains bicisate dihydrochloride (N, N'-1,2-ethylenediylbis-L-cysteine diethyl ester dihydrochloride) and a reducing agent as a lyophilized solid and vial B contains a buffer solution. Both vials are sterile and non-pyrogenic.

Vial A –
Bicisate dihydrochloride (ECD•2HCl) 0.9 mg
Edetate disodium, dihydrate 0.36 mg
Mannitol 24 mg
Stannous chloride, dihydrate, theoretical
(SnCl2•2H2O) 72 µg
Stannous chloride, dihydrate,
minimum (SnCl2•2H2O) 12 µg
Total Tin, (stannous and stannic), dihydrate
(as SnCl2•2H2O) 83 µg

The contents of vial A are lyophilized and stored under nitrogen. The pH of the solution before lyophilization is 2.7 ± 0.25. This vial is stored at 15-25°C. Protect from light.

Vial B –
Sodium phosphate dibasic heptahydrate 4.1 mg
Sodium phosphate monobasic monohydrate 0.46 mg
Water for Injection qs 1 mL

The contents of vial B are stored under air. The pH of the solution is 7.6 ± 0.4. This vial is stored at 15-25°C.

This drug is administered by intravenous injection for diagnostic use after reconstitution with sterile, non-pyrogenic, oxidant-free Sodium Pertechnetate Tc99m Injection. The precise structure of the Technetium complex is [N, N'-ethylenedi-L-cysteinato(3-)]oxo[99mTc] technetium (V), diethyl ester.