METOLOSE® 65SH-5

1 of 32 products in this brand
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.

Chemical Name: Hydroxypropyl Methylcellulose

Functions: Binder, Thickener, Viscosity Modifier

Labeling Claims: 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)

    Knowde Enhanced TDS

    Identification & Functionality

    Pharma & Nutraceuticals Functions
    CAS No.
    9004-65-3
    EC No.
    618-389-6
    Structure

    METOLOSE® 65SH-5 - Structure

    Features & Benefits

    Features

    Better dispersibility.

    Applications & Uses

    Product Applications
    • Dispersing agent.
    • Suitable for sustained release, thickining, suspending

    Properties

    Physical Form
    Appearance
    White or slightly off - white powder, fibrous powder or granules.
    Typical Properties
    ValueUnitsTest Method / Conditions
    Methoxy Content27.0 - 30.0%
    Hydroxypropoxy Content4.0 - 7.5%
    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
    Thermal Properties
    ValueUnitsTest Method / Conditions
    Self Ignition Temperatureapprox. 360°C
    Typical Analysis
    ValueUnitsTest Method / Conditions
    Angle of Repose35 - 50°
    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).

    Regulatory & Compliance

    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)

    Technical Details & Test Data

    Surface Activity

    METOLOSE® can be considered a non-ionic surfactant, as it has both hydrophilic and hydrophobic groups in the molecule. Due to such characteristics, it functions as a superior protective colloid, being effective for the stabilization of emulsions, suspensions, and foams.

    METOLOSE® 65SH-5 - Surface Activity

    Packaging & Availability

    Packaging Type
    Packaging Information

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

    Storage & Handling

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