Gemita Description

Gemcitabine HCL is a nucleoside analogue that exhibits antitumor activity. Gemcitabine HCl is a white to off-white solid. It is soluble in water, slightly soluble in methanol, and practically insoluble in ethanol and polar organic solvents.
Gemcitabine for Injection USP 200 mg: Each vial contains: Gemcitabine hydrochloride USP equivalent to gemcitabine 200 mg, mannitol USP 200 mg, sodium acetate trihydrate USP 12.5 mg, hydrochloric acid USNF and/or sodium hydroxide USNF to adjust pH.
Gemcitabine for Injection USP 1 g: Each vial contains: Gemcitabine hydrochloride USP equivalent to gemcitabine 1.0 gm, mannitol USP 1.0 gm, sodium acetate trihydrate USP 62.5 mg, hydrochloric acid USNF and/or sodium hydroxide USNF to adjust pH.
Gemcitabine for Injection USP 1.4 g: Each vial contains: Gemcitabine hydrochloride USP equivalent to gemcitabine 1.4 gm, mannitol USP 1.4 gm, sodium acetate trihydrate USP 87.5 mg, hydrochloric acid USNF and/or sodium hydroxide USNF to adjust pH.
The chemical name for gemcitabine HCl is 2'-deoxy-2',2'-difluorocytidine monohydrochloride (β-isomer). The empirical formula for gemcitabine HCl is C₉H₁₁F₂N₃O₄ HCl. It has a molecular weight of 299.66. The formulation is supplied in a sterile form for intravenous use only. Vials contain either 200 mg, 1 g and 1.4 g of gemcitabine HCl (expressed as free base) as a sterile lyophilized powder.
Excipients/Inactive Ingredients: Mannitol, sodium acetate trihydrate, hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment.