HYDROMORPHONE (NEXJECT) Description
(hydromorphone hydrochloride injection, USP)
11 DESCRIPTION
Hydromorphone Hydrochloride Injection is available as an aqueous sterile solution, for use in intravenous, intramuscular and subcutaneous administration, and contains hydromorphone as active pharmaceutical ingredient in the form hydrochloride salt. Hydromorphone hydrochloride is an opioid agonist.
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.
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.
Each mL of Hydromorphone Hydrochloride Injection sterile solution contains 0.5 mg, 1 mg, 2 mg, or 4 mg of Hydromorphone Hydrochloride USP, equivalent to 0.44 mg, 0.89 mg, 1.77 mg or 3.55 mg of hydromorphone free base, respectively, 0.24 mg of Lactic Acid USP, 5.40 mg of Sodium Chloride as isotonicity agent, 8.93 mg of Sodium Lactate USP as buffering agent, and Lactic Acid USP and Sodium Hydroxide NF as pH adjusters, in Water for Injection. Hydromorphone Hydrochloride Injection pH range is 3.5 to 5.5.
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Description
11 DESCRIPTION
Hydromorphone Hydrochloride Injection is available as an aqueous sterile solution, for use in intravenous, intramuscular and subcutaneous administration, and contains hydromorphone as active pharmaceutical ingredient in the form hydrochloride salt. Hydromorphone hydrochloride is an opioid agonist.
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.
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.
Each mL of Hydromorphone Hydrochloride Injection sterile solution contains 0.5 mg, 1 mg, 2 mg, or 4 mg of Hydromorphone Hydrochloride USP, equivalent to 0.44 mg, 0.89 mg, 1.77 mg or 3.55 mg of hydromorphone free base, respectively, 0.24 mg of Lactic Acid USP, 5.40 mg of Sodium Chloride as isotonicity agent, 8.93 mg of Sodium Lactate USP as buffering agent, and Lactic Acid USP and Sodium Hydroxide NF as pH adjusters, in Water for Injection. Hydromorphone Hydrochloride Injection pH range is 3.5 to 5.5.
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