L-HPC LH-32
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-32 is suitable for wet granulation, pellet extrusion and layering.
Properties
- Physical Form
- Powder
- Solid
- Pharma and Nutraceuticals Functions
- Binder
- Disintegrant
Product families
Applications
- Oral
- Excipients & Coatings
Product Families
- Binders & Disintegrants
Other characteristics
- Brand
- L-HPC
- Functions
- Binder, Disintegrant
- Labeling Claims
Allergen-free, BSE-free, Kosher, Non-GMO, Solvent-free, TSE-free; Allergen-free; BSE-free; Kosher; Non-GMO; Solvent-free; TSE-free
- Manufacturing Technology
Direct Compression, Tablet Coating, Wet Granulation; Direct Compression; Tablet Coating; Wet Granulation
- 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)
- 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.
- Dosage Form
- Capsules
- Pellets
- Tablets
- Technology
- Pharmaceuticals & Nutraceuticals
- Packaging Type
- Bags
- Drums
- Chemical Inventories
- AICS (Australia)
- DSL (Canada)
- ENCS (Japan)
- IECSC (China)
- KECI (Korea)
- NZIoC (New Zealand)
- PICCS (Phillipines)
- TCSI (Taiwan)
- 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)
Technical data
Table 1 of 2
8 rows| Characteristic | Value | Unit | Method |
|---|---|---|---|
| Chloride | max 0.36 | % | USP/NF |
| Heavy Metals | max. 0.001 | % | USP/NF |
| Hydroxypropoxy Content | 7.0 - 9.9 | % | USP/NF |
| Hydroxypropoxy Content | 8.0 | % | — |
| Loss on drying | max. 5.0 | % | USP/NF |
| Particle Morphology | Micronized | — | — |
| pH | 5.0 - 7.5 | — | JP |
| Residue on ignition | max. 0.5 | % | USP/NF |
Table 2 of 2
3 rows| Characteristic | Value | Unit | Method |
|---|---|---|---|
| Mean Particle Size | 20.0 | μm | — |
| Particle Size (90% cumulated) | 40 - 100 | μm | Shin-Etsu |
| Particle Size (Average) | 17 - 23 | μm | Shin-Etsu |
