L-HPC (low-substituted hydroxypropyl cellulose NF, JP, EP)

  • This dual functioning excipient acts as both a disintegrant and binder.
  • It is not the same as HPC.
  • L-HPC is insoluble in water. It is an effective disintegrant due to its swelling action in water. Because is has good compressibility, it functions as a dry binder.

L-HPC benefits are:

  • Enhanced stability because it is non-ionic and has low water activity
  • It is peroxide free and provides excellent compatibility for oxygen sensitive APIs
  • Improved disintegration

A variety of grades are available depending on the application.


L-HPC LH-B1 is suitable for fluidized-bed granulation, direct compression for high-

load formulations and as a dispersion aid for capsules.

Chemical Name: Low-Substituted Hydroxypropyl Cellulose

Functions: Disintegrant, Dispersant

Dosage Form: Pellets, Tablets

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

    Pharma & Nutraceuticals Functions
    CAS No.
    9004-64-2
    EC No.
    618-388-0
    Structure

    L-HPC LH-B1 - Structure

     

    Features & Benefits

    Features
    • Water insoluble, swells in water and works as dual functional ingredients, disintegrant and binder for tablets and pellets.
    • Suitable grade can be selected depending on process and API characteristics.
    • Non-ionic polymer which has less interaction with API and better stability.

    Applications & Uses

    Dosage Form

    Properties

    Physical Form
    Typical Properties
    ValueUnitsTest Method / Conditions
    Chloride Contentmax. 0.36%USP NF
    Heavy Metals contentmax. 0.001%USP NF
    Hydroxypropoxy Content10.0 - 12.9%USP NF
    Loss on Dryingmax. 5%USP NF
    pH5 - 7.5JP
    Particle Size Distribution
    ValueUnitsTest Method / Conditions
    90% Cummulative Particle Size100 - 150µmShin-Estu
    Mean Particle Size45 - 65µm*Shin-Estu
    Note

    *In-house Laser diffraction method

    Regulatory & Compliance

    Technical Details & Test Data

    Anti-Capping Effect of L-HPC

    L-HPC LH-B1 - Anti-Capping Effect of L-Hpc

    Ethenzamide tablets were prepared with various ratio of excipients and friability test was implemented in accordance with USP method.

     

    Pictures of Aspirin Tablets with Various Excipients (After stability test)

    L-HPC LH-B1 - Pictures of Aspirin Tablets With Various Excipients (After Stability Test)

    Aspirin tablets with 20% excipients were stored in closed plastic bottle at 50°C for 3 months.

     

    Packaging & Availability

    Package
    • 50 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.