Chitosan Biomedical
is produced via farming European spiny lobsters - Palinurus elephas - in a state-of-the-art indoor fully controlled facility. The spiny lobsters are organically grown, without any use of chemicals, antibiotics, nor hormones. During their growth, spiny lobsters naturally generate molts. These by-products have been harvested, without harming the animal, and converts them into chitosan. This resulting product exhibits unparalleled molecular characteristics for biomedical applications.
Unique quality and approach to offer a biomedical chitosan with reproducible biological properties.
PRODUCT SPECIFICATION
Product BIOMEDICAL CHITOSAN, CAS 9012-76-4
Batch n° 2024_001
Production date April 2024
Storage <25 ° C, dry, closed (hydrophilic product)
Shelf life Estimated, 3 years in the conditions above
Raw material European Spiny Lobster*, Palinurus elephas, molts
Country of origin Europe
Usage Non-human research use only
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Parameter
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Specification
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Typical result
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Identification
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FTIR Assay
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Comply with reference
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Solid appearance
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Visual
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White to off white fine powder
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Solution appearance
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Visual
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Clear / colourless
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Degree of deacetylation
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NMR
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> 81%
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Molecular weight (Mw)
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GPC-SEC
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> 390 kDa
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Distribution of Mw
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GPC-SEC
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1.9
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Ashes
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USP Standard ≤1%
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≤1%
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Moisture content
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USP Standard ≤5%
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2.8 %
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Protein content
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USP Standard ≤0.2%
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0 %
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Heavy metals
Pb, Hg, Cd, As
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ICP-MS ≤ 10 ppm
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≤ 1 ppm
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Endotoxins
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<100 EU/g endotoxin LAL
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<100
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Pseudomonas & Staphylococcus
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USP Standard - Absence
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Comply
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Aerobic microbes
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USP Standard <10E3 cfu/g
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<5 cfu/g
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Yeast
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USP Standard <10E2 cfu/g
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<5 cfu/g
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*Sustainably farmed European spiny lobsters, organically grown with no antibiotics, hormones or chemicals.
Note: Cruelty-Free product - Molts (raw material) are obtained without killing or harming the animal as molts are naturally shed by the animal as they grow.
Issue
Research has discovered multiple pharmaceutical/biotech applications for chitosan. These discoveries have yet to benefit patients despite the huge applications potential for the sole reason that reproducible cGMP chitosan is not yet available on the market.
Today's chitosan sources, from large outdoor shrimp farming, high seas' squid to sourcing crustaceans in pristine arctic water, or even relying on different species (insects, fungi) all present variability (up to 20%) due to seasonality of sourcing, lack of purity or harsh processing.
Solution
Our approach, focusing on the well-being of the animal, enables:
● a faster growth than in the wild (up to 5 times)
● the production of an exclusive, naturally generated, stable raw material:
the molts (byproducts)
● no seasonal variations in the raw material composition
● a full traceability all along the production chain (from molts collection to biomedical chitosan batch production)
Thanks to this unique raw material, we are arranging to extract, through a customized proprietary process, a highly pure biomedical chitosan under cGMP that offers:
● Reproducible biological properties
● A high molecular weight (up to 400 kDa)
● A high degree of deacetylation (up to >95% if required).
● Full compliance with the EU and US pharmacopoeia standards.