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L-HPC LH-B1

CAS Number
9004-64-2
EC Number
618-388-0
Chemical Name
Low-Substituted Hydroxypropyl Cellulose

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-B1 is suitable for fluidized-bed granulation, direct compression for high-load formulations and as a dispersion aid for capsules.

Properties

Physical Form
  • Powder
  • Solid
Pharma and Nutraceuticals Functions
  • Disintegrant
  • Dispersant

Product families

Applications

Healthcare & Pharma — Drug Delivery & Care Solutions
  • Oral
Healthcare & Pharma — Pharmaceutical Manufacturing
  • Excipients & Coatings

Product Families

Pharmaceuticals & Nutraceuticals — Excipients
  • Binders & Disintegrants
  • Formulation & Processing Aids

Other characteristics

Brand
L-HPC
Functions
Disintegrant, Dispersant
Dosage Form
  • Pellets, Tablets
  • Pellets
  • Tablets
Labeling Claims

Allergen-free, BSE-free, Kosher, Non-GMO, Solvent-free, TSE-free; 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)

Note
*In-house Laser diffraction method
Grade
Pharma Grade
Markets
Healthcare & Pharma
PACKAGE

50 kg - Fiber drum with polyethylene double bag inside; 1 kg - Polyethylene double bag

Storage

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

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.

Technology
Pharmaceuticals & Nutraceuticals
Packaging Type
  • Bags
  • Drums
  • Totes (IBC)
Chemical Inventories
  • AICS (Australia)
  • DSL (Canada)
  • ENCS (Japan)
  • IECSC (China)
  • KECI (Korea)
  • NZIoC (New Zealand)
  • PICCS (Phillipines)
  • TCSI (Taiwan)
Manufacturing Technology
  • Capsule Filling
  • Direct Compression
  • Wet Granulation
Certifications and 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)

Technical data

Table 1 of 2

5 rows
CharacteristicValueUnitMethod
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 - 7.5—JP

Table 2 of 2

2 rows
CharacteristicValueUnitMethod
90% Cummulative Particle Size100 - 150µmShin-Estu
Mean Particle Size45 - 65µm*Shin-Estu

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