Injection Grade hyaluronic acid Powder
Our injection grade hyaluronic acid powder is manufactured under strict GMP conditions and meets European Pharmacopoeia (EP) standards, with an active FDA Drug Master File (DMF) on record. Sourced from microbial fermentation, this high-purity sodium hyaluronate powder is designed for intra-articular knee injections, viscosupplementation, and veterinary equine joint applications. With tightly controlled molecular weight ranges and intrinsic viscosity, our bulk hyaluronic acid powder delivers consistent rheological performance batch after batch. As a leading bulk hyaluronic acid powder certified supplier, we support pharmaceutical and medical device companies worldwide with custom specifications, competitive pricing, and reliable global logistics.
Formula | [C14H22NNaO11]n |
Synonyms | Sodium Hyaluronate, Hyaluronic Acid, HA |
Appearance | White to off-white Powder |
CAS number | 9067-32-7 |
Purity | >95% |
Source | Fermentation |
classification | High Molecular weight HMW intrinsic viscosity Hyaluronic Acid injection grade Low Molecular weight LMW intrinsic viscosity Hyaluronic Acid injection grade |
Storage | Stored at 2–8°C, protected from light |
What Is Injection Grade Hyaluronic Acid Powder?
Injection grade hyaluronic acid powder, also known as pharmaceutical-grade sodium hyaluronate, is a high-molecular-weight glycosaminoglycan purified to meet stringent pharmacopeial standards for parenteral use. Unlike cosmetic or food-grade HA, injection grade material must pass rigorous tests for endotoxin, protein residue, heavy metals, and microbial bioburden. Our powder is produced via microbial fermentation of Streptococcus equi, yielding a non-animal, highly biocompatible product suitable for knee viscosupplementation, dermal filler raw material, and veterinary joint therapies.
GMP, DMF, FDA & EP Certifications
Our manufacturing facility operates under GMP (Good Manufacturing Practice) conditions, with full batch documentation and traceability from raw material to finished powder. Key regulatory credentials include:
- FDA DMF (Drug Master File): An active Type II DMF is filed with the U.S. FDA, supporting customer ANDA/NDA submissions and 510(k) medical device filings.
- EP Certified: Our hyaluronic acid complies with the current European Pharmacopoeia monograph for Sodium Hyaluronate, including identity, purity, and viscosity limits.
- GMP Certificate: Issued by the competent regulatory authority, covering the full production chain — fermentation, purification, sterilization-grade filtration, and aseptic packaging.
- ISO 9001 / ISO 13485: Quality management systems aligned with medical device and pharmaceutical supply requirements.
All certificates and CoA (Certificate of Analysis) are available upon request for customer qualification audits.
Key Specifications — Molecular Weight & Intrinsic Viscosity
We offer injection grade hyaluronic acid powder in customizable molecular weight (MW) ranges, each optimized for specific injection applications:
| Grade Series | Molecular Weight (MW) Range | Intrinsic Viscosity (IV) | Target Medical Formulation |
|---|---|---|---|
| HA‑INJ‑L | 0.8 M Da‑1.3 M Da | 1.4‑2.1 m³/kg | Mesotherapy, Skin Boosters, Intra‑dermal Injections |
| HA‑INJ‑M | 1.3 M Da‑1.8 M Da | 2.1‑2.7 m³/kg | Knee Viscosupplementation, Soft Tissue Fillers |
| HA‑INJ‑H | 1.8 M Da‑2.5 M Da+ | 2.7‑3.6 m³/kg+ | Ophthalmic Viscoelastic (OVD), Long‑acting Joint Gel |
- Purity (HPLC): ≥ 98.0%
- Protein residue: ≤ 0.1%
- Endotoxin: ≤ 0.05 EU/mg
- Heavy metals: ≤ 10 ppm
- pH (1% solution): 6.0 – 7.5
- Loss on drying: ≤ 10.0%
Applications — Knee & Joint Injection (Human & Equine)
Our injection grade hyaluronic acid powder serves as the core raw material for a wide range of injectable products:
Human Medical Applications
- Intra-articular knee injection: Viscosupplementation for osteoarthritis of the knee, restoring synovial fluid viscosity and providing pain relief.
- Hip, shoulder, and ankle joint injections: Off-label and clinical-use viscosupplementation.
- Dermal filler raw material: Crosslinked HA hydrogels for aesthetic injection (requires additional crosslinking and sterilization steps).
- Ophthalmic surgery: Viscoelastic agents for cataract and refractive procedures.
- Post-surgical adhesion prevention: Barrier gels in abdominal and orthopedic surgery.
Veterinary / Equine Applications
- Horse joint injection: Intra-articular treatment for osteoarthritis and joint inflammation in performance horses (e.g., fetlock, hock, stifle joints).
- Canine and feline joint therapy: Viscosupplementation for companion animals.
- Large animal veterinary use: Custom MW grades for species-specific dosing.
All grades are supplied as sterile-filtered, endotoxin-controlled powder ready for downstream formulation and terminal sterilization.
Frequently Asked Questions (FAQ)
Q: Is your hyaluronic acid powder suitable for direct injection?
A: No. Our powder is a raw material (API / starting material) intended for further formulation, filtration, and terminal sterilization by licensed pharmaceutical or medical device manufacturers before injection.
Q: What is the difference between EP grade and standard grade?
A: EP grade is tested and released against the European Pharmacopoeia monograph for Sodium Hyaluronate, including specific limits on viscosity, protein, and endotoxin. Standard grade meets internal specs but may not carry full EP monograph compliance.
Q: Can you produce custom molecular weight ranges?
A: Yes. We can target MW from 500 kDa to 4,000 kDa with tight polydispersity. Contact our technical team to discuss your formulation requirements.
Q: What is the minimum order for bulk pricing?
A: Bulk pricing tiers begin at 2 kg.
Injection grade HA powder Research Reference
The Effectiveness of Injectable Hyaluronic Acid in the Improvement of the Facial Skin Quality: A Systematic Review
- Several studies have evaluated the role of various injectable formulations of hyaluronic acid (HA) in the improvement of the quality of facial skin. It is important to systematically summarize the available evidence in this regard.