Pure , Ultra-Clean Chitosan
Endotoxin-Free / Terminally Sterile
Product number: DF85-PT49
CAS Number: 9012-76-4
Chitosan synonym: Deacetylated chitin, Poly(D-glucosamine)
Properties
Degree of Deacetylation: >90%
Viscosity (cps): <500
Endotoxin: <10.0 EU/g
Solubility: acetic acid; 1.0%
Starting material: Fresh Crustacean
Appearance: White Flake
Mesh size (mm): 100 - 95% pass
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US $34.14 Per Gram
Minimum Order Quantity: 90 grams
Offer: Limited Time and while Quantities Last
For other payment methods, quantities, or more information…
Description
The ChitoLytic Chitosan – Pure Ultra-Clean Chitosan (cc-PUC) is a Depyrogenated, Terminally Sterile, and Endotoxin-Free chitosan. Its recommended for applications that uses chitosan for implantation and/or parenteral injection.
It forms gels with multivalent anions and clear solutions that dry to strong, clear films. Its ideal for scaffolds, cell therapy, drug delivery, and biomedical applications.
Its a natural biopolmer that’s biocompatible, biodegradable, antibacterial, an adhesive to tissue, and can be used in a variety of applications, e.g.,
Biomedical devices
Micro and Nano encapsulation for controlled release in drug delivery and other therapeutics
Implants
Injectables
cc-PUC goes through this process to achieve a validated pure ultra-clean chitosan;
Clean starting raw material
Processing of the base chitosan from chitin to achieve a pure highly deacetylated and clean chitosan
Testing-1&2 – it’s then validated through a first-phase internal and independent 3rd party assay testing
Plasma-Treated – it’s then treated with a depyrongenated, non-thermal plasma-treatment to further remove heavy-metals and bioburdens. The chitosan is fully depyrogenated, including the complete removal of endotoxin
Testing-3 – a second phase independent 3rd party testing is performed to validate removal of endotoxin
The Plasma-Treatment technology provides consistent results of an endotoxin specification of <1.0 EU/g. Following the Plasma-Treatment, the underlying chitosan remains intact compositionally and functionally.
Are you Implanting or Injecting Chitosan?
Use Pure Ultra-Clean Chitosan to:
Speed up R&D and its documentation
Save R&D time and costs
Increase chances of approval and commercialization
Endotoxin levels in some chitosans, that are intended for biomedical products and devices, can be critical to obtaining regulatory approval. Therefore, addressing and understanding chitosan endotoxin limits is important.
Chitosan continues to be an extensively researched biopolymer for a variety of biomedical applications. A 2019 PubMed search resulted in 27,177 biomedical-related publications cited chitosan as a keyword. This interest can be attributed to chitosan’s utility, such as its biocompatibility, degradability, adhesion to cells and tissue, etc. However, this utility is limited due to some chitosan’s bioburdens and endotoxin level, and the effects it renders on immune responses following parenteral injection and implantation. This causes Standards and Regulatory agencies to be concerned with these chitosans which has shown to compromise the approval process.
ChitoLytic Chitosan – Pure Ultra-Clean (cc-PUC) mitigates these concerns and risks as it’s a chitosan that is depyrogenated and sterile. This can make it essential for some biomedical R&D applications, Regulatory situations, and commercial purposes.
cc-PUC is expensive compared to commodity chitosan products, but can prove to be a better value than its less expensive counterparts.
