Knowde Enhanced TDS
Identification & Functionality
- Chemical Name
- INCI Name
- Ingredient Origin
- Cosmetic Ingredients Functions
- Pharma & Nutraceuticals Functions
- CAS No.
- 9012-76-4
- EC No.
- 618-480-0
- Product Families
- Product Information
- Chemical Description : Chitosan
- Raw Material Basis : Marine (chitin from shrimp shells)
- Manufacturing Procedure : Partial deacetylation of chitin
Features & Benefits
- Benefit Claims
Applications & Uses
- Applications
- Dosage Form
- Manufacturing Technology
- Oral Care Applications
- Treatment Product Applications
- Applications and Uses
- Chitopharm™ CM is a cationic polymer of marine origin. It can be used by any particular customer; it has a defined application in the pharma and med-tech field.
- Chitopharm™ CM is suitable for applications in different fields such as
- Drug delivery
- Wound healing products
- Medical devices
- Cell cultures
- Tissue engineering and dental surgery
Properties
- Appearance
- off white to light pinkish - almost odorless granular powder
- Microbiological Values
- Heavy Metals
- Quality Specifications
- 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
| Value | Units | Test Method / Conditions | |
| Total Aerobic Microbial | 100 | cfu/g | USP/NF 61 |
| Total Combined Molds And Yeast Count | 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 |
| 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 |
| Value | Units | Test Method / Conditions | |
| Identification A | Corresponds | — | USP/NF 197K |
| Identification B | Corresponds | — | USP/NF |
| Apparent Viscosity | TBA | cPs | Intern |
| Degree of Deacetylation | TBA | % | USP monograph <chitosan> |
| Sulfated Ash | 1 | % | USP/NF 281 |
| Loss on Drying (at 105°C) | TBA | % | USP/NF 731 |
| Protein Content | 0.2 | % | USP monograph <chitosan> modified |
| Endotoxin Content | 300 | IU/g | USP/NF 85 |
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. Parameters can vary for specific DDA and MW. For a standard solution of 1%, 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 or 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™ CM 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™ CM 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™ CM 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™ CM. If the tests are within limits, the retest date can be prolonged for another year. Chitopharm™ CM does not contain any preservatives. Store the containers indoor prevented from sunlight.