Enhanced TDS
Knowde-enriched technical product data sheet
Identification & Functionality
- Chemical Name
- INCI Name
- Ingredient Origin
- Cosmetic Ingredients Functions
- Pharma & Nutraceuticals Functions
- CAS No.
- 9012-76-4
- EC No.
- 618-480-0
- Technologies
- Product Families
- Product Information
- Chemical Description : Chitosan powder
- Raw Material Basis : Marine (chitin from shrimp shells)
- Manufacturing Procedure : Partial deacetylation of chitin
Features & Benefits
- Benefit Claims
- Labeling Claims
Applications & Uses
- Markets
- Applications
- Dosage Form
- Manufacturing Technology
- Oral Care Applications
- Treatment Product Applications
- Applications and Uses
- Chitopharm™ S is a cationic polymer of marine origin.
- It can be used for developing
- Films
- Sponges
- Matrices and fleeces
- Chitopharm™ S is suitable for applications in different fields such as
- Drug delivery
- Wound healing products
- Medical devices
- Cell cultures
- Tissue engineering and dental surgery
Properties
- Physical Form
- Appearance
- off white to light pinkish - odorless granular powder
- Microbiological Values
Value Units Test Method / Conditions Total Aerobic Microbial max. 100 cfu/g USP/NF 61 Total Combined Molds And Yeast Count max. 10 cfu/g USP/NF 61 Pseudomonas aeruginosa max. 1 cfu/g USP/NF 61 Staphylococcus aureus max. 1 cfu/g USP/NF 61 Escherichia coli Absent cfu/100ml Ph.Eur. 5.1.4 - Heavy Metals
Value Units Test Method / Conditions Lead Content 0.5 ppm USP/NF 730 Mercury Content 0.2 ppm USP/NF 730 Chromium Content 1 ppm USP/NF 730 Nickel Content 1 ppm USP/NF 730 Cadmium Content 0.2 ppm USP/NF 730 Arsenic Content 0.5 ppm USP/NF 730 Iron Content 10 ppm USP/NF 730 - Quality Specifications
Value Units Test Method / Conditions Identification A Corresponds - USP/NF 197K Identification B Corresponds - USP/NF Apparent Viscosity 50 - 150 cPs Intern Apparent Molecular Weight max. 350 kDa USP monograph <chitosan> Degree of Deacetylation 70 - 95 % USP monograph <chitosan> Sulfated Ash 1 % USP/NF 281 Loss on Drying (at 105°C) 5 % USP/NF 731 Protein Content 0.2 % USP monograph <chitosan> modified Endotoxin Content 300 IU/g USP/NF 85 - Stabilizing Additives / Auxiliaries
- Preservatives : Not present
- Antioxidants : Not present
- Solvents : Not present
- Others : Not present
- Product Properties
- Biodegradability
- BODIS-Test > 70 % readily degradable (ISO 10634)
- Aquatic toxicity
- Acute fish toxicity LC0 > 10,000 mg product/l (semi static, 96 h ISO 7346/2, OECD 203)
- Acute bacteria toxicity ECO 3000 mg product/l (OECD 209)
- Biodegradability
Regulatory & Compliance
- Certifications & Compliance
- Grade
Technical Details & Test Data
- Usage Procedure
In order to obtain a clear, aqueous solution as starting material, a defined amount of acid must be added, e.g. for a 1% solution, per 2 grams of Chitosan, 0.05 mol of acid is needed. It is recommended to only use hydrochloric, glycolic, benzoic, acetic or lactic acid, but citric and tartaric acid is not suitable to use. It is suggested to produce the solution at room temperature or slightly elevated temperature (up to 35⁰C) by using the following procedure: add water to Chitopharm™ S and stir it briefly to obtain a dispersion. Then the acid solution (e.g. pre-dissolved glycolic acid in a small amount of water) should be added at once. Stir the mixture gently until it becomes a clear solution (within 30-60 min). The pH of the resulting solution must be adjusted to pH 4 to 5. The final formulation pH must be less than 6.0. Depending on the intended application, it is recommended to filter the solution before it is incorporated into the product. Chitopharm™ S is not compatible with anionic compounds.
Safety & Health
- Toxicological / Dermatological Information
Information is available in :
- Acute oral toxicity (OECD 401) (literature)
- Skin irritation (expert judgment)
- Mucous membrane compatibility (literature/expert judgment)
- Mutagenicity in vitro (OECD 471) (escape clause/literature)
- Skin sensitization (OECD 406) (analogy)
- Subchronic toxicity (literature)
- Dermal absorption (expert judgment)
Storage & Handling
- Shelf Life
- 4 Years
- Storage & Shelf life
Chitopharm™ S remains stable for at least four years in its original unopened container protected from moisture and at temperatures below 30⁰C. Upon request, Chitinor can test the most critical characteristics of Chitopharm™ S. If the tests are within limits, the retest date can be prolonged for another year. Chitopharm™ S does not contain any preservatives. Store the containers indoor prevented from sunlight.