METOLOSE® 65SH-5

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

Capsules prepared from hypromellose have advantages in comparison with gelatin based capsules. Hypromellose capsules show a better moisture stability and are suitable for vegetarian/vegan patients. Low viscosity hypromellose products like METOLOSE 65SH-5 is suitable for capsule manufacturing.

Properties

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

Product families

Applications

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
Labeling Claims: Allergen-free, BSE-free, Non-GMO, Non-Irritant, TSE-free, Vegan, Vegetarian; Allergen-free; BSE-free; Non-GMO; Non-Irritant; TSE-free; Vegan; Vegetarian
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: Better dispersibility.
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: Dispersing agent.; Suitable for sustained release, thickining, suspending
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)
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	27.0 - 30.0	%
Hydroxypropoxy Content	4.0 - 7.5	%
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