HPMCP is a monophthalic acid ester of hypromellose.HP-55 is a regular grade enteric coating agent.

Chemical Name: Hypromellose Phthalate

Functions: Coating System, Controlled Release Agent, Extended Release Agent, Taste Masker

Dosage Form: Capsules, Pellets, Tablets

Labeling Claims: Allergen-free, BSE-free, Kosher, Non-GMO, TSE-free

Certifications & Compliance: DMF Type IV, European Pharmacopeia (Ph. Eur.), GMP, Japan Pharmacopeia (JP), Kosher, National Formulary (NF), The Food Allergen Labeling & Consumer Protection Act of 2004 (FALCPA), United States Pharmacopeia (USP)

    Knowde Enhanced TDS

    Identification & Functionality

    CAS No.
    9050-31-1
    EC No.
    618-567-3
    Structure

    HPMCP HP-55 - Structure

    Features & Benefits

    Features
    • Suitable for solvent coating system. As co-solvents, mixture of ethanol and water (80/20 w/w%) or mixture of acetone and water (95/5 w/w%) are recommendable.
    • Relatively stable, due to less hydrolysis.
    • Available as a solid dispersion carrier for solubility enhancement.

    Applications & Uses

    Manufacturing Technology
    Application
    • HPMCP is Very Suitable for Taste Masking
    • HPMCP is Very Suitable for Enteric/delayed release coating (solvent)
    • HPMCP is Suitable for Solvent free methods
    • HPMCP is Very Suitable for Solvent methods
    • Tablet Coating
    • Granule Coating

    Properties

    Typical Properties
    ValueUnitsTest Method / Conditions
    ChlorideNot more than 0.07%USP/NF
    Dissolving pHmin. 5.5--
    Free phthalic AcidNot more than 1.0%USP/NF
    Heavy MetalsNot more than 0.001%USP/NF
    Hydroxy propoxy Content5.0 - 9.0%USP/NF
    Labeled Viscosity40.0cSt-
    Methoxy Content18.0 - 22.0%USP/NF
    Nominal Phthalyl Content31.0%-
    phthalyl Content27.0 - 35.0%USP/NF
    Residue on ignitionNot more than 0.20%USP/NF
    Viscosity32 - 48cStUSP/NF
    Viscosity40.0mPa.S-
    WaterNot more than 5.0%USP/NF
    Note

    *Viscosity of 10 w/w% solution of methanol and dichloromethane at 20°C

    Solubility in Various Organic Solvents
      HPMCP Shin-Etsu
    AQOAT
      HP-55
    HP-55S
    HP-50 AS-MG
    Acetone
    Acetone/water (95:5)*
    Acetone/ethanol (1:1)*
    Dichloromethane
    Dichloromethane/ethanol (1:1)*
    Dioxane
    Methanol
    Isopropanol × ×
    Ethanol × × ×
    Ethanol/water (8:2)*
    Ether × × ×

    ○ : soluble, △ : swollen or partially soluble × : insoluble, * : mixing ratio by weight

    Regulatory & Compliance

    Technical Details & Test Data

    Solubility

    HPMCP HP-55 - Solubility

    According to the disintegration test method, dissolution time was measured for cast film from organic solvent (thickness: 100 μ m; size: 10 x 10 mm)
    〜 pH 5.6: USP Phthalate buffer
    pH 5.8 〜: USP Phosphate buffer

    Packaging & Availability

    Packaging Type
    Package
    • 25 kg - Fiber drum with polyethylene double bag inside
    • 1 kg - Polyethylene double bag

    Storage & Handling

    Storage

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