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

11 DESCRIPTION

Hydromorphone Hydrochloride Injection is an opioid agonist, available as an aqueous sterile solution. Each 1 mL of sterile solution contains 1 mg, 2 mg, or 4 mg hydromorphone hydrochloride for use in intravenous, intramuscular and subcutaneous administration. Each 1 mL also contains 5.4 mg sodium lactate and sodium chloride for isotonicity. The chemical name of hydromorphone hydrochloride is 4,5α- epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 321.8 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.

The solution pH is adjusted with lactic acid or sodium hydroxide to between pH 3.5 and 5.5.

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