Hydroxyethylmethyl Cellulose

Basic Information

Name: Hydroxyethylmethyl Cellulose

CAS No: Hydroxyethylmethylcellulose [9032-42-2]

Functional Categories

Coating agent Suspending agent Tablet binder Thickening agent Viscosity-increasing agent

1. Nonproprietary Names

BP: Hydroxyethylmethylcellulose PhEur: Methylhydroxyethylcellulose

2. Synonyms

Cellulose, 2-hydroxyethyl methyl ester; Culminal MHEC; HEMC; hydroxyethyl methylcellulose; hymetellose; MHEC; methylhydroxyethylcellulosum; Tylopur MH; Tylopur MHB; Tylose MB; Tylose MH; Tylose MHB.

3. Chemical Name & CAS Registry

Hydroxyethylmethylcellulose [9032-42-2]

4. Empirical Formula & Molecular Weight

The PhEur 6.0 describes hydroxyethylmethyl cellulose as a partly O-methylated and O-(2-hydroxyethylated) cellulose. Various different grades are available, which are distinguished by appending a number indicative of the apparent viscosity in millipascal seconds (mPa s) of a 2% w/v solution measured at 208C.

6. Applications

Hydroxyethylmethyl cellulose is used as an excipient in a wide range of pharmaceutical products, including oral tablets and suspensions, and topical gel preparations.(1) It has similar properties to methylcellulose, but the hydroxyethyl groups make it more readily soluble in water and solutions are more tolerant of salts and have a higher coagulation temperature.

7. Description

A white, yellowish-white or grayish-white powder or granules, hygroscopic after drying.

8. Pharmacopeial Specifications

See Table I.

9. Typical Properties

Acidity/alkalinity pH = 5.5–8.0 (2% w/v aqueous solution) Moisture content 410% Solubility Hydroxyethylmethyl cellulose is practically insoluble in hot water (above 608C), acetone, ethanol (95%), ether, and toluene. It dissolves in cold water to form a colloidal solution. Viscosity (dynamic) 8.5–11.5 mPa s (8.5–11.5 cP) for Culminal MHEC 8000 2% w/v aqueous solution at 208C.

10. Stability & Storage

Hydroxyethylmethyl cellulose is hygroscopic and should therefore be stored under dry conditions away from heat.

11. Incompatibilities

12. Method of Manufacture

13. Safety

Hydroxyethylmethyl cellulose is used as an excipient in various oral and topical pharmaceutical preparations, and is generally regarded as an essentially nontoxic and nonirritant material. See Hypromellose for further information.

14. Handling Precautions

Observe normal precautions appropriate to the circumstances and quantity of the material handled. Eye protection and gloves are recommended.

15. Regulatory Status

GRAS listed. Included in nonparenteral medicines licensed in Europe (oral suspensions, tablets, and topical preparations).

16. Related Substances

Ethylcellulose; hydroxyethyl cellulose; hypromellose; methylcellulose.

17. Comments