Sodium Hyaluronate – Pharma grade
Chemistry
Sodium hyaluronate is a naturally-occurring polysaccharide.
Sodium Hyaluronate, is a linear copolymer composed of (ß-1,4)-linked D-glucuronate and (ß-1,3)-N-acetyl-D-glucosamine. Sodium Hyaluronate is an abundant glycosaminoglycan found in the extracellular matrix of skin, joints, eyes and most organs and tissues of all higher animals.
Sodium Hyaluronate Pharma Grade is manufactured using Streptococcus Zooepidemicus in a fermentation process, yielding a highly purified, well-characterized sodium hyaluronate developed for use in biomedical and pharmaceutical applications.
The manufacturing site has been operating for over 10 years and is compliant with cGMP guidelines for bulk pharmaceuticals.
Properties
- Non-animal origin
- Highly-purified, low-endotoxins, designed for pharmaceutical and medical applications
- Forms highly viscous aqueous solutions
- Binder, carrier, lubricant
- Promotes cell proliferation and migration
- Bio-absorbable
- Large product line offering to meet various application requirements
The coiled structure of hyaluronate allows entrapment of ~1,000 times its weight in water. This characteristic gives the molecule unique physicochemical properties and distinct biological functions, making it an attractive building block for biocompatible and bio-interactive materials in drug delivery, tissue engineering and visco-supplementation. Sodium hyaluronate will degrade enzymatically in the presence of hyaluronidases. The half-life of hyaluronate in endothelial tissue is less than a day, and the natural turnover of the polymer in adults is approximately 7g per day.
Quality
Sodium Hyaluronate Pharma Grade is a highly purified and well-characterized polymer developed for biomedical and pharmaceutical applications. Sodium Hyaluronate Pharma Grade meets cGMP guidelines; ICH Q7; and ISO standards: ISO 9001:2015 and ISO 14001:2015.
Sodium Hyaluronate Pharma Grade meets current European Pharmacopoeia standards, as well as ASTM F2347 requirements (tissue-engineered medical products). Sodium Hyaluronate Pharma Grade is described in a Drug Master File (DMF) submitted to the U.S. FDA
Application
- Dermal fillers
- Drug delivery
- Osteoarthritis, intra-articular injections
- Replacement of injured cartilage, artificial cartilage grafts
- Anti-adhesion
- Urology
- Tissue engineering, artificial skin grafts for plastic and reconstruction surgery, artificial bone grafts
- Ophthalmologic surgery, intraocular lenses, eye drops and contact lens solutions
Stability
We recommend refrigerated storage (2-8°C) of all Sodium Hyaluronate, apart from Sodium Hyaluronate Pharma Grade GS-300 (HM) which requires frozen storage conditions. Our stability programs show that Sodium Hyaluronate Pharma Grade can be stored at room temperature (25°C) for 6 months without significant reduction of apparent viscosity. For that reason, refrigerated shipping is not required, except for Sodium Hyaluronate Pharma Grade GM-300 (HM).
Product Table
| Product name | Intrinsic Viscosity [m3/kg] | Endotoxin [EU/mg] | Shelf life / Packaging | Regulatory | Typical applications |
|---|---|---|---|---|---|
|
1.2 – 2.0 |
≤ 0.0025 |
3 years 10g or 100g |
- CEP - US DMF |
- First choice for most common medical applications |
|
|
2.1 – 2.8 |
≤ 0.040 |
1 year 10g or 100g |
- CEP - US DMF |
- OVD - API for injections - Catheter coating - Anti adhesion agent |
|
|
1.18 – 1.95 |
≤ 0.003 |
3 years 10g or 100g |
- J DMF - JP - K DMF - Indian API Certificate |
- API for injections - Dermal filler - Catheter coating - Anti adhesion agent |
|
|
0.39 – 0.99 |
≤ 0.040 |
3 years 10g or 100g |
- US DMF - CEP |
- Eye Drop - Topical application |
|
|
1.00 – 2.49
|
≤ 0.040 |
3 years 10g or 100g |
- US DMF - CEP (under registration) - K DMF (under registration) |
- Topical application - Ocular lubricant - Eye drops - Contact lens solution - Wound dressing |
|
|
2.50 – 3.31 |
≤ 0.040 |
18 months 10g or 100g |
- US DMF - CEP |
- Dermal filler - OVD - API for injections - Topical application - Wound dressing - Catheter coating |
|
|
3.32 – 4.60
|
≤ 0.050 |
24 months (Frozen) 10g or 100g |
- CEP - Other filing in process |
- OVD - Catheter coating - API for injections |
CEP = Certificate of Suitability (compliance with European Pharmacopoeia)
US DMF = United States Drug Master File
J DMF = Japanese Drug Master File
JP = Japanese Pharmacopoeia
K DMF = Korean Drug Master File
OVD: Ophthalmic Visco-surgical Device (HA solution for eye surgery)
If you require additional information, including product specifications, please connect with us using our Contact page.