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METOLOSE® SM 1500

CAS Number
9004-67-5
EC Number
618-391-7
Chemical Name
Methylcellulose

METOLOSE® SM 1500 consists of methyl cellulose (USP, JP, EP) and three substitution types of hydroxypropyl methyl cellulose (hypromellose USP, JP, EP) each available in several grades differing in viscosity.

Properties

Physical Form
  • Powder
  • Solid
Pharma and Nutraceuticals Functions
  • Binder
  • Coating System
  • Dispersant
  • 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
  • Pharmaceutical Coatings

Other characteristics

Brand
METOLOSE
Functions

Binder, Coating System, Dispersant, Thickener, Viscosity Modifier

Labeling Claims

Allergen-free, BSE-free, Non-GMO, Non-Irritant, TSE-free; Allergen-free; BSE-free; Non-GMO; Non-Irritant; TSE-free

Certifications & Compliance

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

Note

Viscosity is measured with 2% aqueous solution at 20°C. Viscosity ranges are 80 - 120% for labeled viscosity less than 600 mPa.s and 75 - 140% for labeled viscosity 600 mPa.s and higher, respectively. (Viscosity is harmonized item among the USP, EP and JP).

Grade
Pharma Grade
Markets
Healthcare & Pharma
Features
  • Low thermal gelation temperature.
  • Less sticky.
Appearance

White or slightly off - white powder, fibrous powder or granules.

Technology
Pharmaceuticals & Nutraceuticals
Packaging Type
  • Bags
  • Drums
Storage Information

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

Applications
  • Binder.
  • Dispersing agent.
Packaging Information

Packaging material: Double-layered polyethylene bag in fiber drum.

Regulatory Information

This substance is listed in current Japanese Pharmacopeia, European Pharmacopeia and US Pharmacopeia. This substance is not listed on followings:; Substances restricted under REACH Annex XVII; Authorization List of REACH Annex XIV; Candidate List of SVHCs (Substances of Very High Concern); This substance is listed on the following inventories:; Japanese ENCS (Existing and New Chemical Substances) inventory; United States TSCA (Toxic Substances Control Act) inventory; Canadian DSL (Domestic Substances List); IECSC (Inventory of Existing Chemical Substances Produced or Imported in China); KECTI (Korean Existing Chemicals Inventory); TCSI (Taiwan Chemical Substance Inventory); PICCS (Philippines Inventory of Chemicals and Chemical Substances); AICS (Australian Inventory of Chemical Substances); NZIoC (New Zealand Inventory of Chemicals)

Manufacturing Technology
Wet Granulation
Certifications and Compliance

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

Technical data

Table 1 of 3

8 rows
CharacteristicValueUnit
Methoxy Content26.0 - 33.0%
Viscosity1125 - 2100mPa.s
True Density1.26 - 1.31g/ml
Bulk Density0.20 - 0.45g/ml
Tapped Density0.35 - 0.65g/ml
Degradation Temperature280 - 300°C
HygroscopicityDepends on substitution type—
Dust Explosion100bar.m/s

Table 2 of 3

1 row
CharacteristicValueUnit
Self Ignition Temperatureapprox. 360°C

Table 3 of 3

1 row
CharacteristicValueUnit
Angle of Repose35 - 50°

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