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METOLOSE® 65SH-50

METOLOSE® 65SH-50 is used as a sustained-release agent, thickener, suspending agent and binder for tablets and granules. It is lso used for ophthalmic formulations.

Brand: METOLOSE (32 products)

Chemical Name: Hydroxypropyl Methylcellulose

Functions: Binder, Thickener, Viscosity Modifier

Labeling Claims: Allergen-free, BSE-free, Kosher, Non-GMO, Solvent-free, TSE-free

Certifications & Compliance: DMF Type IV, European Pharmacopeia (Ph. Eur.), FDA Compliant, GMP, Generally Recognized As Safe (GRAS), JECFA (FAO/WHO), Japan Pharmacopeia (JP), REACH (Europe), The Food Allergen Labeling & Consumer Protection Act of 2004 (FALCPA), United States Pharmacopeia (USP)

Enhanced TDS

Knowde-enriched technical product data sheet

Identification & Functionality

Chemical Name: Hydroxypropyl Methylcellulose
Pharma & Nutraceuticals Functions: Binder,
Thickener,
Viscosity Modifier
CAS No.: 9004-65-3
EC No.: 618-389-6
Technologies: Pharmaceuticals & Nutraceuticals
Product Families: Pharmaceuticals & Nutraceuticals — Excipients
Binders & Disintegrants,
Formulation & Processing Aids
Structure

Features & Benefits

Labeling Claims

Features

Non ionic and water soluble polymer with various viscosity.
Applicable as film strips and dispersant of liquid formulation.
SM-4 is recommendable for pellet coating as it is less sticky. The thermal gelling helps to prevent agglomerations during the coating process even at the higher spray speed.

Applications & Uses

Markets: Healthcare & Pharma
Applications: Healthcare & Pharma — Pharmaceutical Manufacturing
Excipients & Coatings

Properties

Physical Form

Typical Properties


	Value	Units	Test Method / Conditions
Heavy Metals	max. 20	ppm	USP
Hydroxy propoxy Content	4.0 - 7.5	%	USP
Loss on drying	max. 5.0	%	USP
Methoxy Content	27.0 - 30.0	%	USP
pH	5.0 - 8.0	-	USP
Residue on ignition	max. 1.5	%	USP
USP Substitution Type	2906.0	-	-
Viscosity	50.0	cps	-
Viscosity	40.0 - 60.0	mPa.S	USP

Note

*Values in the table are viscosities of 2 w/w % aqueous solution at 20°C

Packaging & Availability

Packaging Type

Package

Packaging material: Double-layered polyethylene bag in fiber drum
Net weight: Depending on grades

Storage & Handling

Storage: Keep dry. Store away from excess heat and sunlight. Store in sealed containers.