Product Overview

Hyaluronic Acid is a high-molecular-weight linear polysaccharide used for regulating extracellular hydration and tissue viscoelasticity in formulation systems.

Technical Specifications

Category	Parameter	Specification (Target Value)	Acceptance Range / Limit
Core Physico-chemical	Molecular Weight (MW)	1.50 × 10⁶ Da	1.30 × 10⁶ – 1.80 × 10⁶ Da
	Assay (Sodium Hyaluronate)	98.5%	≥ 98.0%
	PH (1% aqueous solution)	6.5	5.5 – 7.5
	Intrinsic Viscosity	22.0 dL/g	18.0 – 26.0 dL/g
Purity & Safety	Transmittance (1% solution, 550 nm)	99.5%	≥ 99.0%
	Protein Content	0.05%	≤ 0.10%
	Nucleic Acid (A260)	0.20	≤ 0.50
	Loss on Drying	6.0%	≤ 10.0%
	Residue on Ignition	17.5%	15.0% – 20.0%
Microbiological	Total Plate Count	Not detected	< 100 CFU/g
	Molds & Yeasts	Not detected	< 20 CFU/g
	Bacterial Endotoxins	0.02 EU/mg	< 0.05 EU/mg
Heavy Metals	Lead (as Pb)	5 ppm	≤ 10 ppm
Cross-linking (Optional)	Degree of Cross-linking	5.0%	4.0% – 6.0%

Quality Assurance & Compliance

Quality Control
• HPLC testing shows assay levels averaging 99.2%, used to monitor batch-to-batch consistency.

• Endotoxin levels are maintained below 0.03 EU/mg, suitable for injectable-grade requirements.

• Protein residues are below 0.04%, as confirmed by spectrophotometric analysis.

Compliance & Certificates

Certification / Statement	Compliance & Verification
ISO 9001	Applies to quality management system used in manufacturing operations.
FDA DMF	Used for regulatory filing and CMC documentation in pharmaceutical applications.
Non-GMO	Confirms absence of genetically modified organisms in production.
Cruelty-Free	Verifies zero animal testing throughout the development lifecycle.
Vegan	Manufactured via bacterial fermentation without animal-derived materials.
COA & ICP-MS	Certifies batch purity through rigorous heavy metal and microbiological analysis.

Manufacturing & R&D Capability

Bio-Fermentation: Uses Streptococcus bioreactors for controlled batch fermentation.

Industrial Scale: Annual production capacity is 200 metric tons.

Environmental Controls: Manufacturing is carried out in Class 100,000 cleanroom environments.

Tailored Molecular Weights: Controls specific polymer chain lengths via calibrated enzymatic degradation parameters.

Instrumental Analytics: Utilizes SEC-MALS and gas chromatography for precise polymer characterization.

Supply Chain & Logistics Reliability

Logistics & Storage Element	Specification & Operational Target
Standard Packaging	1kg aluminum foil bag / 25kg fiber drum (Moisture-barrier sealed)
Storage Temperature	2–8°C (Climate-controlled, dark environment)
Shelf Life	24 months (Under specified storage conditions)
Global Lead Time	Lead time is 7–14 days to major North American and European ports.
Inventory Status	Safety stock is maintained for continuous supply.

Applications

Application Field	Typical Use
Topical Cosmetics	Formulated into serums, creams, and lotions.
Dermal Fillers	Injected into targeted subcutaneous tissue layers.
Ophthalmic Surgery	Administered as a viscoelastic cushioning fluid.
Intra-articular	Injected directly into osteoarthritic joint spaces.
Wound Care	Applied via medicated dressings and hydrogels.

FAQ

Q: Can your technical team modify the bulk density to meet our specific automatic encapsulation equipment requirements?

A: Yes, particle density can be adjusted for different filling equipment requirements.

Q: Can you provide customized commercial documentation matching the importing country's specific customs tariff codes?

A: Commercial invoices and certificates of origin can be prepared according to HS code requirements.

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