HPC-SSL USP/NF/EP/JP

HPC-SSL USP/NF/EP/JP is a powdered excipient primarily composed of hydroxypropylcellulose. It adheres to various regulatory standards, including the European Pharmacopeia (Ph. Eur.), Japan Pharmacopeia (JP), National Formulary (NF), and is compliant with TSCA Exempt (USA) and United States Pharmacopeia (USP) requirements. This water-soluble excipient is utilized in pharmaceutical applications, particularly as a formulation and processing aid. It is distinguished by its non-carcinogenic labeling claim, affirming its safety for pharmaceutical formulations.

Supplied By: NISSO

Product Code: P01886

Regional Availability: USA

Chemical Name: Hydroxypropylcellulose

Functions: Binder, Coating System, Film Former, Granulation Aid, Thickener, Viscosity Modifier

Dosage Form: Tablets

Labeling Claims: Additive-free, Allergen-free, Gluten-free, Halal, Kosher, Non-Carcinogenic, Non-Genetically Modified Organism (GMO), Non-Reactive, Non-Toxic, Not Tested on Animals, Vegan, Vegetarian

Certifications & Compliance: European Pharmacopeia (Ph. Eur.), FSC Certified, GMP, Hazard Analysis Critical Control Point (HACCP), ISO 14001, ISO 9001, Japan Pharmacopeia (JP), National Formulary (NF), United States Pharmacopeia (USP)

    Enhanced TDS

    Identification & Functionality

    Chemical Family
    Cellulose & Cellulosics
    Chemical Name
    Hydroxypropylcellulose
    Supplied By
    NISSO
    Pharma & Nutraceuticals Functions
    Binder,
    Coating System,
    Film Former,
    Granulation Aid,
    Thickener,
    Viscosity Modifier
    Technologies
    Pharmaceuticals & Nutraceuticals
    Product Families
    Pharmaceuticals & Nutraceuticals — Excipients
    Binders & Disintegrants,
    Formulation & Processing Aids,
    Pharmaceutical Coatings

    Features & Benefits

    Labeling Claims
    Additive-free,
    Allergen-free,
    Gluten-free,
    Halal,
    Kosher,
    Non-Carcinogenic,
    Non-Genetically Modified Organism (GMO),
    Non-Reactive,
    Non-Toxic,
    Not Tested on Animals,
    Vegan,
    Vegetarian

    Applications & Uses

    Markets
    Healthcare & Pharma
    Applications
    Healthcare & Pharma — Drug Delivery & Care Solutions
    Oral
    Healthcare & Pharma — Pharmaceutical Manufacturing
    Excipients & Coatings,
    Pharmaceutical Processing
    Segments
    Pharmaceuticals
    Applications
    Pharmaceuticals — Excipients
    Dosage Form
    Tablets
    Manufacturing Technology
    Direct Compression,
    Dry Granulation,
    Granulation,
    Hot Melt Extrusion,
    Wet Granulation

    Properties

    Physical Form
    Powder
    Soluble In
    Cold Water Soluble
    Concentration Change Graph in Aqueous Solution

    Concentration Change Graph in Aqueous Solution

    Note
    • This analysis is according to USP42-NF37.
    •  
    • Class2 solvent, toluene listed in USP <467> is used for the manufacturing of Nisso HPC.
    • The amount of toluene is monthly checked, using USP <467>.
    • The obtained results are not more than 20ppm (LOQ) for the specification of 890ppm.
    • There is no use of the organic solvents (chloroform; 1,4-dioxane; methylene chloride; tri-chloroethylene) during the manufacturing process of Nisso HPC, and no contaminant of during shipping or storage.
    • Nisso HPC is free from Silica.
    • The amount of Silica is monthly checked, using USP42-NF37.
    • The obtained results are not more than 0.06% (LOQ) for the specification of 0.6%.
    • There is no use of anti-caking agent (Silica) during the manufacturing process of Nisso HPC.
    Concentration Change Graph in Ethanol Solution

    Concentration Change Graph in Ethanol Solution

    Temperature Change Graph in Aqueous Solution

    Temperature Change Graph in Aqueous Solution

    Product Structure

    NISSO HPC-SSL_1

    Product Structure

    NISSO HPC-SSL_2

    Chemical Structure

    HPC Structure

    Particle Size Distribution
      D₁₀ (µm) D₅₀ (µm) D₉₀ (µm)
    HPC-SSL 30 85 185
    HPC-SL 65 155 275
    HPC-L 75 160 355
    HPC-M 80 185 355
    HPC-H 85 185 365
    HPC-VH 85 185 365
    FP Grades 35 - 50 80 - 110 150 - 200
    SFP Grade 8 20 50

    NISSO HPC Particle Size Distribution Table

    Regulatory & Compliance

    Certifications & Compliance
    European Pharmacopeia (Ph. Eur.),
    FSC Certified,
    GMP,
    Hazard Analysis Critical Control Point (HACCP),
    ISO 14001,
    ISO 9001,
    Japan Pharmacopeia (JP),
    National Formulary (NF),
    United States Pharmacopeia (USP)
    Chemical Inventories
    TSCA Exempt (USA)

    Packaging & Availability

    Packaging Type
    Box
    Regional Availability
    • USA

    Storage & Handling

    Shelf Life
    5 years