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HYDROMORPHONE HYDROCHLORIDE, Vial U.S. Physician Prescribing Information (hydromorphone hydrochloride injection, USP) Description

11 DESCRIPTION

Hydromorphone Hydrochloride, a hydrogenated ketone of morphine, is an opioid agonist.

Hydromorphone Hydrochloride Injection, USP [high potency formulation (HPF)] is available as a sterile, aqueous solution in single-dose amber vials, for intravenous, subcutaneous, or intramuscular administration. Each single-dose vial contains 10 mg/mL of hydromorphone hydrochloride with 0.2% sodium citrate and 0.2% citric acid added as a buffer to maintain a pH of between 3.5 and 5.5.

The chemical name of hydromorphone hydrochloride is 4,5α- epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 321.8. Its molecular formula is C17H19NO3∙ HCl, and it has the following chemical structure:

Chemical Structure

Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride.

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