SPL Set ID: 4dcda284-cfea-4b95-b432-a3d5af536e63

1 drug(s) with this SPL Set ID

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Carboprost Tromethamine CARBOPROST TROMETHAMINE
ANI PHARMACEUTICALS, INC. FDA Rx Only

Carboprost Tromethamine Injection USP, 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 Carboprost Tromethamine Injection USP. 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: The molecular formula is C 25 H 47 O 8 N. 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 Carboprost Tromethamine Injection USP contains carboprost tromethamine equivalent to 250 mcg of carboprost, 83 mcg tromethamine, 9 mg sodium chloride, 9.45 mg benzyl alcohol added as preservative, and water for injection. When necessary, pH is adjusted with sodium hydroxide and/or hydrochloric acid. The solution is sterile. Structure

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