Description

Icodextrin is a high molecular weight, glucose polymer derived from starch hydrolysis, specifically designed for peritoneal dialysis solutions. Its unique colloid osmotic properties make it an essential osmotic agent for long-dwell exchanges, offering superior ultrafiltration compared to traditional glucose-based solutions. This product is critical for pharmaceutical manufacturers developing advanced renal care therapies and is supplied to meet the stringent requirements of the global medical and biotechnology sectors. Icodextrin CAS NO 337376-15-5 represents a key ingredient for improving patient outcomes in chronic kidney disease management.

Application

• Peritoneal Dialysis Solutions: Primary osmotic agent in icodextrin-based dialysis fluids for long-dwell (e.g., 8-16 hour) exchanges, providing sustained ultrafiltration.
• Pharmaceutical Formulations: Used as a plasma volume expander and in other parenteral drug delivery systems requiring a high molecular weight carbohydrate.
• Biotechnology Research: Employed as a macromolecular agent in cell culture media and as a stabilizer in diagnostic reagent formulations.
• Controlled-Release Matrices: Acts as a biodegradable polymer matrix for the sustained release of active pharmaceutical ingredients (APIs).

Basic Information

Product Name	Icodextrin
CAS No.	337376-15-5
Molecular Formula	(C6H10O5)n
Molecular Weight	~13,000 - 19,000 Da (Average)
Synonyms	Extraneal; Glucose Polymer; Polyglucose; α-D-Glucan; Poly(α-1,4-D-glucose); Poly(α-1,6-D-glucose); Maltodextrin (high molecular weight fraction); Dialysis Solution Polymer
EINECS	Contact for details

Quality Control

Our Icodextrin is manufactured under strict quality management systems to ensure it meets the rigorous standards required for pharmaceutical applications. Each batch is tested against comprehensive specifications, including identity, purity, molecular weight distribution, and absence of critical impurities. Certificates of Analysis (COA) are provided, detailing compliance with relevant pharmacopeial monographs (e.g., USP, EP) and internal specifications. We are committed to supply chain transparency and regulatory support for our global partners.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, well-ventilated area at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive). Keep the container tightly sealed in a dry environment to prevent moisture absorption, which can affect product stability and performance.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms
Assay (HPLC)	≥ 95.0% (as Icodextrin)
pH (5% solution)	4.5 - 7.0
Heavy Metals	≤ 10 ppm
Residual Solvents (GC)	Meets ICH guidelines
Microbial Limits	Meets Ph. Eur. 2.6.12 / USP <61>
Endotoxin (LAL)	< 0.05 EU/mg

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.