SPL Set ID: cc3df863-c51c-49c5-283a-d6808fb49258

Pralatrexate is a dihydrofolate reductase inhibitor. Pralatrexate has the chemical name (2S)-2-[[4-[(1RS)-1-[(2, 4-diaminopteridin-6-yl)methyl]but-3- ynyl]benzoyl]amino]pentanedioic acid. The molecular formula is C 23 H 23 N 7 O 5 and the molecular weight is 477.48 g/mol. Pralatrexate is a 1:1 racemic mixture of S- and R- diastereomers at the C10 position (indicated with *). The structural formula is as follows: Pralatrexate is an off-white to yellow hygroscopic powder. The pH is 4.45 (in 1% aqueous suspension). Pralatrexate is soluble in dimethyl sulfoxide and sparingly soluble in dimethyl formamide. The pKa values are 3.25, 4.70, and 6. Pralatrexate injection is supplied as a preservative-free, sterile, isotonic, non-pyrogenic clear yellow aqueous solution contained in a clear glass single-dose vial (Type I) for intravenous use. Each 1 mL of solution contains 20 mg of pralatrexate, 6.4 mg of sodium chloride to achieve an isotonic (280-300 mOsm) solution, and sufficient sodium hydroxide, and hydrochloric acid if needed, to adjust and maintain the pH at 7.5-8.5. Pralatrexate injection is supplied as either 20 mg (1 mL) or 40 mg (2 mL) single-dose vials at a concentration of 20 mg/mL. Structural Formula