Hercules Incorporated Aqualon Division Hercules Plaza 1313 North Market Street Wilmington, DE 19894-0001 (800) 345-0447 www.aqualon.

com

Product Data
NUMBER 4110-3 (Supersedes 4110-2)

NATROSOL 250 Pharm Hydroxyethylcellulose

NATROSOL 250 Pharm hydroxyethylcellulose (HEC) is a nonionic, water-soluble polymer. Chemically, it is cellulose that has been etherified to give solubility in water. It is provided as white to offwhite, free-flowing powder.
Uses

Natrosol 250 Pharm HEC can be used as (a) a modified release tablet matrix, (b) a thickener, stabilizer and suspending agent for oral and topical applications, and (c) a film former. For modified release tablets, higher viscosity grades provide effective diffusion-limiting matrix systems at use levels of 15-40%, most suited for active ingredients with low water solubility, where near zero-order release is desired. Medium or high viscosity grades are used to control rheology, providing thickening and pseudoplasticity, and to stabilize emulsions. Emulsions stabilized with HEC exhibit high salt tolerance and surfactant compatibility. Clear solutions and gels may be formulated. Higher viscosity grades yield greater thickening efficiency. Lower viscosity grades impart flexibility to films while providing a good barrier to water and oxygen transmission.
Outstanding Characteristics

Natrosol HEC dissolves readily in water to give clear, smooth, nonthixotropic solutions. Because it is nonionic, its solubility is largely independent of dissolved salts. Its viscosity is only minimally affected by the presence of mild acids and bases. The product is soluble in hot or cold water up to practical viscosity limits. Although the material is not soluble in organic solvents, it is soluble in some water/organic solvent blends. Alcohol may be added, up to a level of 30%, to an aqueous solution of HEC without precipitation. These grades of HEC are not surface-treated. To ensure lump-free solution preparation, please see the handling guidelines in Aqualon Bulletin VC-515: Natrosol HydroxyethylcelluloseTechniques for Dispersion and Dissolution. (over)
The products and related information provided by Hercules are for manufacturing use only. Hercules makes no express, implied, or other representation, warranty, or guarantee concerning (i) the handling, use, or application of such products, whether alone, in combination with other products, or otherwise, (ii) the completeness, definitiveness, or adequacy of such information for users or other purposes, (iii) the quality of such products, except that such products are of Hercules standard quality. Users are advised to make their own tests to determine the safety and suitability of each such product or product combination for their own purposes. Read and understand the Material Safety Data Sheet (MSDS) before using this product. Hercules does not recommend any use of its products that would violate any patent or other rights.
HER. 41286/04-01 PRINTED IN U.S.A.

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Natrosol HEC has excellent compatibility with a large number of natural and synthetic watersoluble polymers.
Viscosity Types

Natrosol 250 Pharm HEC is available in four viscosity types:

Brookfield LVF Viscosity at 25C, mPa.s Type HHX Pharm H and HX Pharm M Pharm G Pharm in 1% Solution 3,500-5,500 1,500-2,500 in 2% Solution appr. 100,000 appr. 30,000 4,500-6,500 250-400 Viscosity, Measured at 10 s-1 and 25C in 2% Solution 17,000 11,000 5,000 330

Current Specifications for Natrosol 250 Pharm hydroxyethylcellulose (HEC): Hercules Specification for Natrosol 250 Pharm Hydroxyethylcellulose Off-white 4.0 max 1.0 max 6.0-8.5 5 max 3.0 max 0.2 max 1.0 max 20 max 3 max 3 max 10 max 1 max 10 max max 0.5% max 10%

Product Aspect Product color Ash (calculated as Na2SO4 ), % Natrosol 250 G Pharm* All other types pH (1% solution) Moisture (as packed), % Nitrate, % Natrosol 250 G Pharm* All other types Chlorides, % Heavy metals (as lead), ppm Lead, ppm Arsenic, ppm Glyoxal, ppm Ethylene oxide, ppm 2-Chloroethanol, ppm Particle size X-types, retained on 60 mesh Standard-types, retained on 40 mesh

*Low molecular weight hydroxyethylcellulose with an apparent viscosity of 1,000 mPa.s or less

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Stability

Bacterial contamination can reduce the viscosity of HEC solutions. Preservatives should be used in any solution of HEC that is to be stored.
Regulatory Status

Natrosol 250 Pharm HEC can be used in oral and topical drug products as an inert ingredient. The product meets the monograph requirements of the current editions of the European Pharmacopoeia and the National Formulary. Aqualon holds a Drug Master File for this product. CASRN: CAS Name:
Product Safety

9004-62-0 Cellulose, 2-hydroxyethyl ether

Read and understand the Material Safety Data Sheet (MSDS) for Natrosol HEC before using this product.

10-05

Hercules Incorporated, 2005.

PRINTED IN U.S.A.