Average Molecular Weight: 13,000~19,000 Da Dextrose Equivalent (DE): ≤3.0% Loss on Drying: ≤4.50% Residue on Ignition: <0.10% Heavy Metal(Pb):<10ppm Arsenic:<2ppm Microbial Limit: Total aerobic count <100CFU/g, no E.Coli/Salmonella Related monosaccharide impurity: Glucose+Maltose ≤1.20%

Icodextrin is a pharmacopoeia-grade biocompatible colloid osmotic API refined from hydrolyzed maltodextrin/starch with α-1,4 glycosidic linkage dominant and less than 10% α-1,6 branched bonds, mainly formulated into sterile peritoneal dialysis infusion for clinical nephrology treatment. The 7.5% isotonic aqueous formulation (Extraneal) serves as long-dwell peritoneal dialysate for end-stage renal failure patients including diabetic nephropathy for CAPD and APD therapy, relying on colloid osmotic pressure to sustain ultrafiltration across peritoneum for fluid removal. Another licensed formulation (Adept) is applied as intraoperative anti-adhesion solution after abdominal & laparoscopic gynecologic surgeries to reduce postoperative tissue adhesion formation via physical isolation effect. High-purity reference standard grade is used for pharmacopoeia HPLC testing, dialysis solution finished-product QC inspection and pharmaceutical CRO formulation development; partial custom-grade material is explored for sustained-release excipient and wound dressing biomaterial research in biomedical labs. Not allowed for oral or direct food application.

GHS classification: Warning with hazard codes H302(acute oral toxicity low grade), H315 skin irritant, H319 severe eye irritation, H335 dust inhalation hazard. Operators shall wear nitrile gloves, dustproof safety goggles and lab dust-proof coat during powder weighing and solution compounding to prevent dust inhalation and mucosa contact. Upon skin contact, rinse thoroughly with running clean water over 15 minutes; continuous eye flush minimum 15 min with plenty of water once splashed and consult physician for persistent irritation. Accidental small oral intake rarely triggers discomfort, massive ingestion may induce bloating and gastrointestinal upset requiring symptomatic treatment. Waste powder and aqueous residual liquid are categorized as general pharmaceutical waste following local environmental regulation, prohibited from direct sewer discharge. Store separately from strong acid, strong alkali and oxidizing agents to prevent polysaccharide hydrolytic degradation into low-molecular sugar and avoid microbial spoilage under damp warm surroundings.