Hyaluronan

Sodium Hyaluronate Pharma Grade

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Sodium Hyaluronate Pharma Grade is a highly purified and well-characterized sodium hyaluronate developed for use in biomedical and pharmaceutical applications. Sodium Hyaluronate Pharma Grade is produced by NovaMatrix® strategic partner, Kikkoman Biochemifa Company (KBC), Japan . The fermentation of ultra pure sodium hyaluronate is based on more than 10 years of experience and the plant is constructed and run in compliance with cGMP guidelines for bulk pharmaceuticals. The ultra pure sodium hyaluronates from Kibun is described in a DMF submitted to the US FDA. In addition to sodium hyaluronate, NovaMatrix® also provides ultra pure alginate and chitosan, poly-anionic and poly-cationic polymers, respectively, that can be used in combination with hyaluronan.

Sodium Hyaluronate, fermented from Streptococcus zooepidemicus, 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. It is the only non-sulfated glycosaminoglycan and forms highly viscous aqueous solutions.

The viscosity is a direct result of the polymer expanded random coil structure a consequence of strong hydrogen bounding. The coiled structure of hyaluronate can trap approximately 1000 times its weight in water. These characteristics give the molecule unique physicochemical properties as well as distinct biological functions and suggest it as an attractive building block for new biocompatible and biointeractive materials in drug delivery, tissue engineering and viscosupplementation.

Hyaluronic acid or hyaluronate is a natural component in mammalian organisms and will suffer from polymer chain enzymatic degradation by 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 a day. A mild to moderate covalent modification of hyaluronan will increase the in vivo stability and retention time from days up to months or year. The biomechanical properties of the polymer are also improved by covalent modification technologies. Current modifications are concentrated to the carboxyl group and hydroxyl group on the D and N monomer units respectively and polymer cross-linking technologies.

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Quality

Sodium Hyaluronate Pharma Grade is a highly purified and well-characterized sodium hyaluronate developed for biomedical and pharmaceutical applications. Our Sodium Hyaluronate Pharma Grade is produced by NovaMatrix® strategic partner, KBC, in compliance with applicable Japanese law and GMP guidelines; ICH Q7; and ISO standards: ISO 9001:2008 and ISO 14001:2004.

Sodium Hyaluronate Pharma Grade meets the standards set forth in the current edition of the European Pharmacopoeia, and satisfies the requirements for use in tissue-engineered medical products as set forth in ASTM F2347. Sodium Hyaluronate Pharma Grade is described in a DMF submitted to the U.S. FDA

Applications examples

  • Dermal fillers
  • Osteoarthritis, intra-articular injections
  • Anti-adhesion
  • Drug delivery
  • Ophthalmic surgery
  • Urology
  • Tissue engineering, artificial skin grafts for plastic and reconstruction surgery, artificial bone grafts
  • Replacement of injured cartilage, artificial cartilage grafts
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Sodium Hyaluronate Pharma Grade 80

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

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Sodium Hyaluronate Pharma Grade 150

  • Intrinsic Viscosity [m3/kg] : 2.1-2.8
  • Appr. Mw [kDa] : 1200-1900
  • Endotoxins [EU/g]: ≤ 40

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Product

Intrinsic Viscosity [m3/kg]

Appr. Mw [kDa]

Endotoxins [EU/g]

1.2-2.0

620-1200

≤ 2.5

2.1-2.8

1200-1900

≤ 40