Sterile Water For Injection I.P. (500ML)

Sterile Water for Injection is prepared using Multi column Distillation Plant by feeding Purified Water. Below are the specification of the Sterile WFI,

• • Conductivity = Less than 1.3 MicroS/Cm
  • Temperature = Room Temperature
  • Endotoxin = Less than 025 EU/ml
  • Heavy metals = Less than 0.1 PPM
  • Acidity Or Alkalinity = Resulting is not red for acidity & not blue for alkalinity.
  • Ammonium = Resulting solution is not more intensely colored than the std solution (0.2FPM).
  • Calcium & Magnesium = Resulting Solution is pure blue
  • Heavy Metals = NMT-0.1 PP1 Pb
  • Chlorides = Resulting solution is unchanged for at least 15 mins (0.5PFm)
  • Nitrates = Resulting solution is not more intensely colored than the std solution (0.2FPM).
  • Sulphates = Resulting Solution is unchanged for at least one hour.
  • Oxidizable Substances = Resulting solution remains faintly pint
  • Clarity & Color Solution = When examined in suitable condition of visibility , it is clear , colorless and practically free from suspended particles.
  • Residue on Evaporation = NMT 0.004% (4.0mg)
  • Sterility = 0 Comply as per I.P.
  • Bacterial Endotoxins = Less than 0.25 EU\ml