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Sodium Hyaluronate Pharma Grade 80

$75,00 / gram

Minimum 10g.
The volume ordered can be incremented by 10 grams minimum value.

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SKU: Product# 4266107 Category:

Description

Sodium Hyaluronate Pharma Grade FCH 80 is based on a sodium hyaluronate fermented from Streptococcus zooepidemicus harvested and purified to an extreme degree of purity. The residual levels of endotoxins and proteins allows for use directly in vivo without need for any allergenic tests prior to administration. The product has a molecular weight in the 620000 – 1150000 g/mol range (calculated from intrinsic viscosity data). Sold per gram, minimum order is 10 grams.

  • Intrinsic Viscosity [m3/kg] : 1.2-2.0
  • Appr. Mw [kDa] : 620-1200
  • Endotoxins [EU/g]: ≤ 2.5

Specifications

Generic Name

Sodium hyaluronate

Storage

Store in an airtight container, protected from light and humidity, at 2-8°C

Identification - IR Spectrum

Exhibits absorbance at about 3400 cm-1, 2900 cm-1, 1610 cm-1, 1400 cm-1, 1040 cm-1 and 610 cm-1

Identification - Reaction of sodium

Dense white precipitate is formed

Absorbance at 600 nm

Not more than 0.01

Appearance

Clear solution

pH

5.5 – 8.5 (0.5% aqueous solution)

Intrinsic viscosity

1.2 – 2.0 m3/kg

Nucleic acid (absorbance at 260nm)

Not more than 0.2

Protein

Not more than 0.1%

Ethanol

Not more than 1.0%

Heavy metals

Not more than 10ppm

Chlorides

Not more than 0.5%

Iron

Not more than 80ppm

Loss on drying

Not more than 10.0%

Microbial contamination (bioburden)

Not more than 20 cfu/g

Bacterial endotoxins

Not more than 2.5 EU/g

Assay

95.0 – 105.0%

Quality

NovaMatrix® produces and supplies well-characterized and documented ultrapure, bio-compatible and bio-absorbable biopolymers for use in the pharmaceutical, biotechnology and biomedical industries.

These may include, but not be limited to applications such as drug delivery, tissue engineering, cell encapsulation, and medical devices. For our ultrapure sodium alginates and sodium hyaluronate, we maintain Drug Master Files with the US FDA.

NovaMatrix® products are intended to be used in applications which require high and consistent quality provided by our manufacturing, Quality Control and Quality Assurance. NovaMatrix® manufacture PRONOVA™ sodium alginate in our facilities in Norway. We operate according to GMP guidelines; ICH Q7, ICH Q1, ICH Q2 and ISO standards; ISO 9001:2008 and ISO 13485:2003.

Furthermore NovaMatrix® holds the Manufacturing License for API’s issued by the Norwegian Medicine Agency (NOMA). Our Sodium Hyaluronate ultrapure products are produced using non-animal origin sources by our partner, Kikkoman Biochemifa Company, Japan, under GMP guidelines; the Pharmaceutical and Madical Devices Act, ICH Q7 and ISO standards; ISO 9001:2008 and ISO 14001:2004.

Safety & toxicology

Application examples

Dermal Fillers, Osteoarthritis, Anti-Adhesion, Drug Delivery, Eye surgery, Urology, Tissue Engineering, Replacement of Injured Cartilage.