Hydroxypropyl Cellulose, Low-Substituted Hydroxypropyl Cellulose, HPC, L-HPC, 9004-64-2

Hydroxypropyl Cellulose, Low-Substituted Hydroxypropyl Cellulose, HPC, L-HPC, 9004-64-2

HYDROXYPROPYL CELLULOSE (HPC)

PRODUCT IDENTIFICATION INFORMATION

CHEMICAL STRUCTURE

Hydroxypropyl Cellulose Structure:

        CH₂OR
        |
    O — C — H      R = H or CH₂CH(OH)CH₃
    |   |   |
    H — C — O — H
        |
        CH₂OR

Structure Description:

• Cellulose ether derivative.

• Hydroxypropyl groups (-CH₂CH(OH)CH₃) are attached to the cellulose backbone.

• Degree of substitution (DS) and molar substitution (MS) determine properties.

• Non-ionic, water-soluble cellulose ether.

SECTION 1: CHEMICAL IDENTITY AND DESCRIPTION

SECTION 2: PHYSICAL AND CHEMICAL PROPERTIES

SECTION 3: HYDROXYPROPYL CELLULOSE vs OTHER CELLULOSE ETHERS

SECTION 4: MECHANISM OF ACTION

SECTION 5: PRODUCTION PROCESS

Industrial Production Method:

Process Flow:
Cellulose (Wood Pulp/Cotton Linters) → Alkali Treatment (NaOH) → Propylene Oxide Reaction → Etherification → Neutralization → Washing → Drying → Milling → Final Product

Step-by-Step Description:

1. Alkali Treatment: Cellulose is treated with sodium hydroxide solution to form alkali cellulose.

2. Etherification: Alkali cellulose is reacted with propylene oxide under pressure and controlled temperature.

3. Neutralization: The reaction mixture is neutralized with acid to adjust pH.

4. Washing: Product is washed with water and/or organic solvents to remove by-products and impurities.

5. Drying: Purified product is dried to achieve desired moisture content.

6. Milling: Dried product is milled to achieve desired particle size distribution.

7. Final Product: Various grades with different molecular weights and substitution levels are produced.

SECTION 6: FUNCTIONAL PROPERTIES

SECTION 7: MAIN APPLICATION AREAS

SECTION 8: SAMPLE FORMULATIONS

Pharmaceutical Tablet Binder (Wet Granulation):

Instructions: Dissolve HPC in water or ethanol/water mixture to form binder solution; Add to powder blend during granulation; Dry, mill, and compress into tablets.

Ophthalmic Solution (Artificial Tears):

Instructions: Dissolve HPC in water with stirring; Adjust pH to 5.0-7.5; Add preservatives if required; Sterilize by filtration; Package in sterile containers.

SECTION 9: QUALITY SPECIFICATIONS

SECTION 10: TOXICOLOGICAL PROFILE

SECTION 11: GHS CLASSIFICATION AND LABELING

GHS Classification (in accordance with CLP and UN GHS):

Signal Word: None (Not classified as hazardous)

Hazard Pictograms: None

NFPA 704 Hazard Classification:

SECTION 12: PRECAUTIONARY STATEMENTS (P-CODES)

SECTION 13: FIRST AID MEASURES

SECTION 14: FIREFIGHTING MEASURES

SECTION 15: STORAGE AND SHELF LIFE

SECTION 16: PACKAGING OPTIONS

SECTION 17: TRANSPORT INFORMATION

SECTION 18: REGULATORY STATUS

SECTION 19: OTHER NAMES AND SYNONYMS

SECTION 20: SUMMARY TABLE

SECTION 21: CRITICAL WARNINGS AND BEST PRACTICES

CRITICAL WARNINGS:

• GRAS Status: Generally Recognized as Safe (GRAS) by FDA; Approved for use in pharmaceuticals, cosmetics, and foods.

• Non-Toxic: Low toxicity; Non-irritating to skin; May cause mild eye irritation (transient).

• Hygroscopic: Absorbs moisture from air; Store in tightly closed containers.

• Combustible Dust: May form explosive dust-air mixtures; Avoid dust cloud formation.

• Thermoreversible Gelation: Unique property of HPC; Forms gel upon heating; Useful in controlled-release and topical formulations.

• Viscosity Depends on Molecular Weight: Different grades available for different applications; Choose appropriate grade based on desired viscosity.

• Wide Application Range: Pharmaceuticals (binder, film former, matrix former), cosmetics (thickener, emulsifier), food (stabilizer), biotechnology (DNA separation), cultural heritage (paper conservation).

• Ophthalmic Use: Used in artificial tears; Provides lubrication for dry eyes; Treatment of keratoconjunctivitis sicca, corneal erosions, neuroparalytic keratitis.

• Vegan: Derived from cellulose (plant source); Suitable for vegan and vegetarian applications.

BEST PRACTICE RECOMMENDATIONS:

• Pharmaceutical Applications: Use as binder in wet and dry granulation; Dosage: 2-5% of formulation; Dissolve in water or ethanol/water mixture; Also used as film former, matrix former, and mucoadhesive agent.

• Ophthalmic Applications: Use as lubricant and viscosity enhancer; Dosage: 0.5-2%; Dissolve in purified water; Adjust pH to 5.0-7.5; Sterilize by filtration.

• Cosmetic Applications: Use as thickener, emulsifier, and film former; Dosage: 0.5-5%; Dissolve in aqueous phase with agitation; Add active ingredients after dissolution.

• Food Applications: Use as thickener and stabilizer; Dosage: 0.1-2%; Follow local regulatory requirements (Turkish Food Codex, EFSA, FDA).

• Handling: Use in well-ventilated areas; Avoid dust formation; Use dust masks when handling powder; Use gloves and safety goggles.

• Personal Protective Equipment: Dust mask (N95/FFP2 or higher) if dust is generated, safety goggles, chemical-resistant gloves, protective clothing.

• Hygiene: Wash hands thoroughly after handling; Do not eat, drink, or smoke while using; Remove contaminated clothing and wash before reuse.

• Storage: Store in tightly closed, moisture-proof containers; Store in a cool, dry, well-ventilated area; Protect from moisture and heat; Opened containers must be resealed immediately; Shelf life: 24-48 months under proper conditions.

• Spill Management: Sweep or vacuum (HEPA) and place in suitable sealed container; Avoid dust formation; Do not allow entry into drains or waterways.

• Disposal: Dispose of in accordance with local, regional, and national regulations; Non-hazardous waste; Can be incinerated in compliance with regulations.

DETECTION METHODS:

HYDROXYPROPYL CELLULOSE (HPC) vs ALTERNATIVES COMPARISON:

LEGAL DISCLAIMER:
The information provided in this document is based on our current knowledge and experience and is presented in good faith. However, as all conditions of use are beyond our control, it does not constitute a binding specification or warranty. This Technical Data Sheet is for informational purposes only. Users are responsible for testing the suitability for their own applications and for complying with all local, regional, and national regulations. For complete safety, storage, use, handling, waste, and regulatory compliance information, please refer to the official Safety Data Sheet (SDS/MSDS) provided by the manufacturer/supplier.