Description

Product Name: Low-Endotoxin Sodium Hyaluronate
Molecular Weight Range: Varies (specific range available upon request)
Appearance: Clear, colorless solution
Molecular Formula: (C14H21NO11)n
Molecular Weight: Varies (specific weight available upon request)

Key Features:
1.High Purity: Manufactured through biofermentation, ensuring a non-animal origin and low endotoxin levels.
2.Certified Quality: Produced in facilities certified with ISO 9001, ISO 14001, HACCP, and GMP standards.
3.Versatile Applications: Suitable for eye drops, ophthalmic surgeries, injectable formulations, and cosmetic products.
4.Enhanced Safety: Endotoxin content ≤ 0.05 EU/mg, protein content ≤ 0.1%, ensuring minimal risk of adverse reactions.

Product Specifications:
Endotoxin Content: ≤ 0.05 EU/mg
Protein Content: ≤ 0.1%
pH (0.5% solution in water): 5.0 – 8.5
Loss on Drying: ≤ 20.0%
Clarity (A600nm): ≤ 0.01
Nucleic Acid (A260nm): ≤ 0.5
Iron Content: ≤ 80 ppm
Ethanol Residual: < 0.4%
Oxidants: ≤ 0.5%
Dry Weight Loss: ≤ 20.0%

Certificate of Analysis (COA)

Testing Items	Standard
Solution Appearance	Soution Clanification
pH Value	A600nm≤0
Intrinsic Viscosity	5.0-8.5
Nucleic Acid	A260nm5.0-8.5
Protein	≤0.1%
chloride	≤0.5%
cutter	≤80ppm
Loss on Drying	≤20.0%
Ethanol Residue	<0.4%
Bacterial Endotoxins	≤0.051U/mg
Sterility	Should meet the specified
Sodium Hyaluronate (%)	95.0%～105.0%

Applications:
Medical: Used in eye drops, ophthalmic surgeries, and injectable formulations.
Cosmetic: Incorporated into skincare products for its hydrating and anti-aging properties.
Nutraceutical: Utilized in dietary supplements for joint health and skin elasticity.

Why Choose Us:
Advanced Manufacturing: Utilizing state-of-the-art ultrafiltration and adsorption technologies to ensure product purity.
Regulatory Compliance: Adherence to international standards and certifications guarantees product quality and safety.
Global Reach: Serving B2B clients worldwide, including manufacturers, wholesalers, and brand owners.
Customer Support: Dedicated team providing technical assistance and tailored solutions to meet specific needs.

Storage Recommendations:
Temperature: Store in a cool, dry place.
Packaging: Keep in tightly sealed containers to prevent contamination.
Shelf Life: Refer to product-specific data sheets for expiration dates.

Frequently Asked Questions (FAQ) — Low-Endotoxin Sodium Hyaluronate

1. What is Low-Endotoxin Sodium Hyaluronate?

Low-Endotoxin Sodium Hyaluronate is a high-purity, biofermented active pharmaceutical ingredient (API) produced with advanced purification technologies to ensure endotoxin levels below 0.05 EU/mg. It is widely used in ophthalmic, injectable, cosmetic, and nutraceutical applications that require strict safety and biocompatibility standards.

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2. How is the low endotoxin level achieved?

The product is refined through multi-stage ultrafiltration, ion-exchange, and adsorption purification processes that effectively remove endotoxins, proteins, and other impurities while maintaining molecular integrity. Continuous quality monitoring ensures compliance with pharmacopeial and GMP standards.

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3. What are the typical endotoxin and purity specifications?

• Endotoxin level: ≤ 0.05 EU/mg

• Purity (HPLC): ≥ 99%

• Moisture content: ≤ 10%

• pH (0.1% solution): 6.0–8.0
  These parameters can be customized according to client formulation or regulatory requirements.

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4. What molecular weight ranges are available?

Our Low-Endotoxin Sodium Hyaluronate is available in a wide range of molecular weights to suit different formulation needs:

• Low molecular weight: 100 kDa – 500 kDa (injection or transdermal use)

• Medium molecular weight: 800 kDa – 1,500 kDa (ophthalmic or cosmetic use)

• High molecular weight: 1,800 kDa – 3,000 kDa (viscosupplement or film-forming use)

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5. What certifications and standards does your product comply with?

• GMP-certified manufacturing facility

• ISO 9001 (Quality Management)

• ISO 14001 (Environmental Management)

• Complies with EP, USP, and JP monograph standards for Sodium Hyaluronate

• COA and Microbial Test Report provided with each batch

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6. What are the recommended applications?

• Pharmaceutical: Ophthalmic solutions, injectable fillers, wound-healing products

• Cosmetic: Moisturizing serums, anti-aging creams, facial masks

• Nutraceutical: Joint-health supplements, skin hydration capsules, oral beauty products

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7. What is the shelf life and storage condition?

• Shelf life: 2 years from manufacturing date

• Storage: Store in a cool, dry, and well-ventilated area, away from direct sunlight and heat sources. Reseal containers tightly after opening.

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8. Can you provide technical documents such as COA or Test Report?

Yes. Each batch comes with a Certificate of Analysis (COA), Test Report, and Material Safety Data Sheet (MSDS) upon request. Third-party testing or customized analysis reports can also be arranged.

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9. Do you offer customized grades or formulation support?

Yes. We provide custom molecular weight adjustment, endotoxin level control, and formulation consulting to support your product development in pharmaceutical, cosmetic, or nutraceutical applications.

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10. How can I request samples or place an order?

Please contact our sales team with your application details and molecular weight requirements. Samples are available for evaluation, and bulk orders can be arranged with technical support and international shipping options.