SPL Set ID: 8d170f6f-37d7-41ce-aae2-33307a6ef3ae

Cisplatin Injection, USP is a colorless to yellowish clear, sterile aqueous solution available in amber vials. Each 50 mL amber vial of infusion concentrate contains: 1 mg/mL cisplatin, USP, 9 mg/mL sodium chloride, hydrochloric acid and sodium hydroxide to adjust pH, and water for injection to a final volume of 50 mL, respectively. The pH range of Cisplatin Injection, USP is 3.2 to 6.0. Cisplatin Injection, USP must be further diluted prior to administration (see DOSAGE AND ADMINISTRATION, All Patients ). The active ingredient, cisplatin, USP, is a yellow to orange crystalline powder with the molecular formula PtCl 2 H 6 N 2 , and a molecular weight of 300.1. Cisplatin, USP is a heavy metal complex containing a central atom of platinum surrounded by two chloride atoms and two ammonia molecules in the cis position. It is soluble in water or saline at 1 mg/mL and in dimethylformamide at 24 mg/mL. It has a melting point of 207°C. Figure