DEFINITION

Hydrocortisone Sodium Succinate for Injection is a sterile mixture of Hydrocortisone Sodium Succinate and suitable buffers. It may be prepared from Hydrocortisone Sodium Succinate, or from Hydrocortisone Hemisuccinate with the aid of Sodium Hydroxide or Sodium Carbonate. It contains the equivalent of NLT 90.0% and NMT 110.0% of the labeled amount of hydrocortisone (C₂₁H₃₀O₅) in single-compartment containers, or in the volume of solution designated on the label of containers that are constructed to hold, in separate compartments, the Hydrocortisone Sodium Succinate for Injection and a solvent.