SPL Set ID: ffaf9462-cdd8-433b-8b03-464a35577fe9

Octreotide acetate injection, a cyclic octapeptide prepared as a clear sterile solution of octreotide, acetate salt, in a buffered acetic acid solution for administration by deep subcutaneous or IV injection. Octreotide acetate, known chemically as L-Cysteinamide, D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-[2-hydroxy-1-(hydroxymethyl) propyl]-,cyclic (2 → 7)-disulfide; [R-(R*, R*)] acetate salt, is a long-acting octapeptide with pharmacologic actions mimicking those of the natural hormone somatostatin. Octreotide acetate injection is available as sterile 1-mL single dose vials in 3 strengths, each mL containing 50 mcg, 100 mcg, or 500 mcg octreotide acetate, USP as the active ingredient and sterile 5-mL multi-dose vials in 2 strengths, containing 200 and 1,000 mcg/mL of octreotide acetate, USP as the active ingredient. Each mL of the single-dose vials also contains following inactive ingredients: glacial acetic acid, USP.......................................................................................................................................2 mg sodium acetate (trihydrate), USP........................................................................................................................2 mg sodium chloride, USP.........................................................................................................................................7 mg water for injection........................................................................................................... quantity sufficient to 1 mL Each mL of the multi-dose vials also contains following inactive ingredients: glacial acetic acid, USP......................................................................................................................................2 mg sodium acetate (trihydrate), USP........................................................................................................................2 mg sodium chloride, USP.........................................................................................................................................7 mg phenol, USP .......................................................................................................................................................5 mg water for injection............................................................................................................ quantity sufficient to 1 mL Glacial acetic acid, USP and sodium acetate (trihydrate), USP are added to provide a buffered solution, pH to 3.9 to 4.5. The molecular weight of octreotide acetate is 1019.3 g/mol (free peptide, C 49 H 66 N 10 O 10 S 2 ) and its amino acid sequence is: chemical-structure