Summary
A pyrogen-free mannitol used for parenteral preparations and Rx injections,and offers the benefits of excipients and API.
Characteristic
▪Endotoxin <1.25 EU / g or <0.625 EU / g without pyrogen.
▪As excipients, it’s isotonic agent and filler of lyophilized powder for injection or infusion.
▪As API, it has many functions: small and large volume intravenous injection of permeable diuretics, renal function diagnostic agent, adjuvant therapy for acute renal failure, cerebral edema reduces intracranial pressure, reducing intraocular pressure and antidote.
Specifications and Applications
product name:Crystalline Mannitol
Product Specification:Pyrogen Free
Application:
Osmotic diuretics in small and large volume parenteral injections
Isotonic Agent and Fillers for Freeze-dried Powders for Rx injection or infusion
applicable standard:
CP/USP/EP/BP/JP/IP
E421/FCC/GB1886
Certifications:
ISO9001、ISO14001、ISO22000、HACCP、KOSHER、HALAL、GMP、FDA、CDE
