Monographs: Pharmaceutical substances: Hydroxyethylcellulose (Hydroxyethylcellulosum)Chemical name. Cellulose 2-hydroxyethyl ether; CAS Reg. No. 9004-62-0. Description. A white or yellowish white powder or granules; odourless or almost odourless. Solubility. Soluble in hot and cold water forming a colloidal solution; practically insoluble in acetone R, ethanol (~750 g/l) TS, ether R, and toluene R. Category. Stabilizer; suspending agent. Storage. Hydroxyethylcellulose should be kept in a well-closed container. Labelling. The designation on the container of hydroxyethylcellulose should state its viscosity. Additional information. Hydroxyethylcellulose may contain suitable anti-caking agents. After drying, it is hygroscopic. Requirements Definition. Hydroxyethylcellulose is a partially substituted poly(hydroxyethyl) ether of cellulose. Identity tests
Heavy metals. Use 1.0 g for the preparation of the test solution as described under 2.2.3 Limit test for heavy metals, Procedure 3; determine the heavy metals content according to Method A; not more than 20 μg/g. Sulfated ash. Not more than 50 mg/g. Loss on drying. Dry to constant mass at 105 °C; it loses not more than 100 mg/g. pH value. pH of the solution prepared in identity test A, 5.5-8.5. Reducing substances. Add 5 mL of water to 5 mL of the solution prepared in identity test A, then add 15 drops of sulfuric acid (0.5 mol/l) VS and 1.5 mL of potassium permanganate (0.002 mol/l) VS. Heat the mixture to 50 °C for not less than 5 minutes; the colour of the solution remains unchanged.
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