TYLOPUR® 645 is a versatile hypromellose, compliant with USP, JP, EP. It is a film coating material that provides an excellent finish.It is a effective binder, it does not interact with drugs.It also enhances the solubility of poorly solule APIs.

Chemical Name: Hydroxypropyl Methylcellulose

Functions: Binder, Thickener, Viscosity Modifier

Dosage Form: Capsules, Orally Disintegrating Films (ODFs), Pellets, Tablets

Labeling Claims: Allergen-free, Halal, Kosher, Non-GMO, Plant-Based

Certifications & Compliance: EU Compliant, EXCiPACT, European Pharmacopeia (Ph. Eur.), FCC Compliant, FDA Compliant, FSSC 22000, GMP, Generally Recognized As Safe (GRAS), Halal, ISO 14001, ISO 9001, Japan Pharmacopeia (JP), Kosher, United States Pharmacopeia (USP)

    Knowde Enhanced TDS

    Identification & Functionality

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

    Features & Benefits

    Applications & Uses

    Manufacturing Technology

    Properties

    Physical Form
    Typical Properties
    ValueUnitsTest Method / Conditions
    Heavy Metalsmax. 20ppm
    Hydroxypropoxy Content7.0 - 12.0%
    Loss on Dryingmax. 5.0%
    Methoxy Content28.0 - 30.0%
    pH5.0 - 8.0EP
    Sulphated Ash /Residue On Ignitionmax. 1.5%EP
    Visocity3.6 - 5.1mPas
    Coating Properties
    ValueUnitsTest Method / Conditions
    Inlet Air Flow (Coating Parameters)Constantm3/h
    Inlet Air Flow (Coating Parameters)400.0m3/h
    Inlet Air Temperature (Coating Parameters)80.0⁰C
    Nozzle Pressure Bar (Coating Parameters)0.65bar
    Nozzle Pressure Bar (Coating Parameters)2.9bar
    Pan Speed (Coating Parameters)22.0rpm
    Pan Speed (Coating Parameters)5 (during 5min) - 12rpm
    Spray Rate (Coating Parameters)4.2 - 5.9g/min
    Spray Rate (Coating Parameters)6 - 23g/min
    Tablet Bed Temperature during Coating38 - 40⁰C
    Tablet Bed Temperature during Coating35 - 40⁰C
    Tablet Bed Temperature during Coating40.0⁰C
    Processing Parameters
    ValueUnitsTest Method / Conditions
    Disintegration Time474.0S
    Dissolution(>80%) min10.0

    Regulatory & Compliance

    Packaging & Availability

    Packaging Type