ZINECARD Solution for injection Ref.[27445] Active ingredients: Dexrazoxane

Source: FDA, National Drug Code (US)  Revision Year: 2021 

Product description

Proper name: Dexrazoxane

Chemical name: (S)4,4'(1-methyl-1,2-ethanediyl)bis[2,6-piperazinedione]

Molecular formula and molecular mass: C11H16N4O4 and 268.28

Structural formula:

Physicochemical properties: ZINECARD (dexrazoxane) is a sterile, lyophilized, parenteral, cardioprotective agent for use in conjunction with anthracycline. It is a white to off-white crystalline powder.

It is sparingly soluble in water and 0.1 N HCl, slightly soluble in acetonitrile, ethanol, methanol and water/dimethylacetamide (1:1), and practically insoluble in non-polar organic solvents. Its melting range is 187-197°C. The acidic pKa value of dexrazoxane at 25°C is 2.1. The alkaline pKa’s are 10.1 and 11.1. The partition coefficient, expressed as the dexrazoxane concentration in 1-octanol divided by the aqueous phase concentration, is 0.025 at 25°C.

Dosage Forms and Strengths

ZINECARD (dexrazoxane) is available in:

250 mg single dose vial, for reconstitution with recommended diluent.
500 mg single dose vial, for reconstitution with recommended diluent.

Diluent not provided.

The 250 mg vial contains 250 mg of dexrazoxane; pH is adjusted with hydrochloric acid, NF.

The 500 mg vial contains 500 mg of dexrazoxane; pH is adjusted with hydrochloric acid, NF.

Drugs

Drug Countries
ZINECARD Canada, United States

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