METOLOSE® SM 4000
METOLOSE® SM 4000 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
- Oral
- Excipients & Coatings
Product Families
- 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| Characteristic | Value | Unit |
|---|---|---|
| Methoxy Content | 26.0 - 33.0 | % |
| Viscosity | 3000 - 5600 | mPa.s |
| True Density | 1.26 - 1.31 | g/ml |
| Bulk Density | 0.20 - 0.45 | g/ml |
| Tapped Density | 0.35 - 0.65 | g/ml |
| Degradation Temperature | 280 - 300 | °C |
| Hygroscopicity | Depends on substitution type | — |
| Dust Explosion | 100 | bar.m/s |
Table 2 of 3
1 row| Characteristic | Value | Unit |
|---|---|---|
| Self Ignition Temperature | approx. 360 | °C |
Table 3 of 3
1 row| Characteristic | Value | Unit |
|---|---|---|
| Angle of Repose | 35 - 50 | ° |
