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METOLOSE® 60SH-10000

CAS Number
9004-65-3
EC Number
618-389-6
Chemical Name
Hydroxypropyl Methylcellulose

METOLOSE® 60SH-10000 is used as a sustained-release agent, thickener, suspending agent and binder for tablets and granules. It is lso used for ophthalmic formulations.

Properties

Physical Form
  • Powder
  • Solid
Pharma and Nutraceuticals Functions
  • Binder
  • Thickener
  • Viscosity Modifier

Product families

Applications

Healthcare & Pharma — Drug Delivery & Care Solutions
  • Oral
Healthcare & Pharma — Pharmaceutical Manufacturing
  • Excipients & Coatings

Product Families

Pharmaceuticals & Nutraceuticals — Excipients
  • Binders & Disintegrants
  • Formulation & Processing Aids

Other characteristics

Brand
METOLOSE
Functions
Binder, Thickener, Viscosity Modifier
Dosage Form
Orally Disintegrating Films (ODFs)
Labeling Claims

Allergen-free, BSE-free, Kosher, Non-GMO, Solvent-free, TSE-free; 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)

Note

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

Grade
Pharma Grade
Markets
Healthcare & Pharma
PACKAGE
Packaging material
Double-layered polyethylene bag in fiber drum
Net weight
Depending on grades
Storage

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

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.

Technology
Pharmaceuticals & Nutraceuticals
Packaging Type
  • Bags
  • Drums
Chemical Inventories
  • AICS (Australia)
  • DSL (Canada)
  • ENCS (Japan)
  • IECSC (China)
  • KECI (Korea)
  • NZIoC (New Zealand)
  • PICCS (Phillipines)
  • TCSI (Taiwan)
Certifications and 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)

Technical data

Table 1 of 1

9 rows
CharacteristicValueUnitMethod
Heavy Metalsmax. 20ppmUSP
Hydroxy propoxy Content7.0 - 12.0%USP
Loss on dryingmax. 5.0%USP
Methoxy Content28.0 - 30.0%USP
pH5.0 - 8.0—USP
Residue on ignitionmax. 1.5%USP
USP Substitution Type2910.0——
Viscosity10000.0cps—
Viscosity7500 - 14000mPa.SUSP

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