L-HPC LH-31

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-31 is suitable for wet granulation, pellet extrusion and layering.

Brand: L-HPC (11 products)

Chemical Name: Low-Substituted Hydroxypropyl Cellulose

Manufacturing Technology: Direct Compression, Tablet Coating, Wet Granulation

Functions: Binder, Disintegrant

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

Knowde-enriched technical product data sheet

Identification & Functionality

Chemical Name: Low-Substituted Hydroxypropyl Cellulose
Pharma & Nutraceuticals Functions: Binder,
Disintegrant
CAS No.: 9004-64-2
EC No.: 618-388-0
Technologies: Pharmaceuticals & Nutraceuticals
Product Families: Pharmaceuticals & Nutraceuticals — Excipients
Binders & Disintegrants
Structure

Features & Benefits

Labeling Claims

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

Markets: Healthcare & Pharma
Applications: Healthcare & Pharma — Drug Delivery & Care Solutions
Oral
Healthcare & Pharma — Pharmaceutical Manufacturing
Excipients & Coatings
Dosage Form: Capsules,
Pellets,
Tablets
Manufacturing Technology: Direct Compression,
Tablet Coating,
Wet Granulation

Properties

Physical Form

Typical Properties


	Value	Units	Test Method / Conditions
Chloride	min. 0.36	%	USP/NF
Heavy Metals	min. 0.001	%	USP/NF
Hydroxypropoxy Content	11.0	%	-
Hydroxypropoxy Content	10.0 - 12.9	%	USP/NF
Loss on drying	min. 5.0	%	USP/NF
Particle Morphology	Micronized	-	-
pH	5.0 - 7.5	-	JP
Residue on ignition	Not more than 0.5	%	USP/NF

Particle Size Distribution


	Value	Units	Test Method / Conditions
Mean Particle Size	20.0	μm	-
Particle Size (90% cumulated)	40 - 100	μm	Shin-Etsu
Particle Size (Average)	17 - 23	μm	Shin-Etsu

Note

*In-house Laser diffraction method

Regulatory & Compliance

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)
Chemical Inventories: AICS (Australia),
DSL (Canada),
ENCS (Japan),
IECSC (China),
KECI (Korea),
NZIoC (New Zealand),
PICCS (Phillipines),
TCSI (Taiwan),
TSCA (USA)
Grade: Pharma Grade

Technical Details & Test Data

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

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.