DEFINITION

Cyclophosphamide for Injection is a sterile mixture of Cyclophosphamide with or without a suitable excipient. The sterile powder formulation contains NLT 90.0% and NMT 105.0% of the labeled amount of anhydrous cyclophosphamide (C₇H₁₅Cl₂N₂O₂P). The lyophilized formulation contains NLT 90.0% and NMT 110.0% of the labeled amount of anhydrous cyclophosphamide (C₇H₁₅Cl₂N₂O₂P).