Iron Sucrose Complex (Pyrogen Free)

Iron Sucrose Complex (Pyrogen Free)

• Description : Reddish deep brown colored amorphous powder, with characteristic odour. Amorphous and hygroscopic in nature.
• Identification : Ferric Iron: It gives blue colour with Potassium Ferrocyanide
• Sucrose: It gives green colour with Anthrone Reagent.
• Solubility : 10% w/v easily soluble in water , without any Sedimentation .
• Loss On Drying : NMT 5% at 1050C (On Moisture Balance) Alkalinity
• (2% w/v Iron solution) : Between 0.5 – 0.8ml of 0.1N hydrochloric acid consumed / ml.
• pH of 2% w/v solution : 9.0 to 11.0 Turbidity
• (2% w/v Iron solution) : Turbidity should develop between pH 4.4 – 5.3.
• Tapped Bulk Density : 0.65 to 0.8
• Chlorides as NaCl : NMT 1%  Specific gravity at 200C
• (2% w/v Iron solution) : NLT 1.135 – NMT 1.165
• Total Microbial Count : NMT 100CFU/gm
• Bacterial Endotoxin Test : NMT 3.7 EU/mg of Iron
• Pathogens : Should be absent
• Assay Of Sucrose : 70% to 95% (On dried basis)
• Assay of Iron : 4.0% w/w to 6.0% w/w (On dried basis)