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HEMABATE® (carboprost trometamol) Description

DESCRIPTION

HEMABATE Sterile Solution, an oxytocic, contains the tromethamine salt of the (15S)-15 methyl analogue of naturally occurring prostaglandin F2α in a solution suitable for intramuscular injection.

Carboprost tromethamine is the established name for the active ingredient in HEMABATE. Four other chemical names are:

  1. (15S)-15-methyl prostaglandin F2α tromethamine salt
  2. 7-(3α,5α-dihydroxy-2ß-[(3S)-3-hydroxy-3-methyl-trans-1-octenyl]-1α-cyclopentyl]-cis-5-heptenoic acid compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol
  3. (15S)-9α,11α,15-trihydroxy-15-methylprosta-cis-5, trans-13-dienoic acid tromethamine salt
  4. (15S)-15-methyl PGF2α-THAM

The structural formula is represented below:

Chemical Structure

The molecular formula is C25H47O8N. The molecular weight of carboprost tromethamine is 489.64. It is a white to slightly off-white crystalline powder. It generally melts between 95° and 105° C, depending on the rate of heating.

Carboprost tromethamine dissolves readily in water at room temperature at a concentration greater than 75 mg/mL.

Each mL of HEMABATE Sterile Solution contains carboprost tromethamine equivalent to 250 mcg of carboprost, 83 mcg tromethamine, 9 mg sodium chloride, and 9.45 mg benzyl alcohol added as preservative. When necessary, pH is adjusted with sodium hydroxide and/or hydrochloric acid. The solution is sterile.

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