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sufentanil citrate injection, USP Description

11 DESCRIPTION

Sufentanil Citrate Injection, USP is a sterile, nonpyrogenic solution of sufentanil citrate in water for injection. Sufentanil Citrate is a potent opioid analgesic which is administered either epidurally or by intravenous injection.

Each mL contains sufentanil citrate equivalent to 50 mcg of sufentanil. May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. pH 4.2 (3.5 to 6.0).

The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended for use only as a single-use injection. When smaller doses are required, the unused portion should be discarded in an appropriate manner.

Sufentanil Citrate, USP, occurs as a white crystalline powder and is chemically designated as N-[-4-(methyoxymethyl)-1-[2-(2-thienyl)ethyl]-4-piperidinyl]-N-phenylpropanamide 2-hydroxy-1,2,3-propanetricarboxylate (1:1).

The molecular formula of sufentanil citrate is C22H30N2O2S∙C6H8O7 and the molecular weight is 578.69. Sufentanil Citrate has the following structural formula:

Chemical Structure
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