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L-HPC LH-11

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 activityIt is peroxide free and provides excellent compatibility for oxygen sensitive APIsImproved disintegrationA variety of grades are available depending on the application.L-HPC LH-11 is suitable for direct compression and prevents capping during compression.

Brand: L-HPC (11 products)

Chemical Name: Low-Substituted Hydroxypropyl Cellulose

Functions: Binder, Disintegrant, Dispersant

Dosage Form: Capsules, 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)

Enhanced TDS

Enhanced TDS

Knowde-enriched technical product data sheet

Identification & Functionality

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

L-HPC LH-11 - 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

Manufacturing Technology

Properties

Physical Form
Typical Properties
ValueUnitsTest Method / Conditions
Chloride Contentmin. 0.36%USP NF
Heavy Metals contentmin. 0.001%USP NF
Hydroxypropoxy Content10.0 - 12.9%USP NF
Loss on Dryingmin. 5%USP NF
pH5 - 7.5-JP
Particle Size Distribution
ValueUnitsTest Method / Conditions
90% Cummulative Particle Size150 - 200µm*Shin-Estu
Mean Particle Size45 - 65µm*Shin-Estu
Note

*In-house Laser diffraction method

Regulatory & Compliance

Technical Details & Test Data

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

L-HPC LH-11 - 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.

 

Anti-Capping Effect of L-HPC

L-HPC LH-11 - 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.

 

Packaging & Availability

Packaging Type
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.