METOLOSE - 65SH-400 - Shin-Etsu - 9004-65-3

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: Allergen-free,
BSE-free,
Kosher,
Non-GMO,
Solvent-free,
TSE-free
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: Powder,
Solid
Typical Properties
Note: *Values in the table are viscosities of 2 w/w % aqueous solution at 20°C

	Value	Units	Test Method / Conditions
Methoxy Content	27.0 – 30.0	%
Hydroxypropoxy content	4.0 – 7.5	%

Regulatory & Compliance

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)
Chemical Inventories: AICS (Australia),
DSL (Canada),
ENCS (Japan),
IECSC (China),
KECI (Korea),
NZIoC (New Zealand),
PICCS (Phillipines),
TCSI (Taiwan),
TSCA (USA)
Grade: Pharma Grade

Packaging & Availability

Packaging Type: Bags,
Drums
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.

METOLOSE® 65SH-400