Knowde Enhanced TDS
Identification & Functionality
- INCI Name
- Cosmetic Ingredients Functions
- CAS No.
- 9004-65-3
- Technologies
Features & Benefits
- Benefit Claims
- Labeling Claims
Applications & Uses
- Markets
- Applications
- Bath & Shower Applications
- Hair Care Applications
- Personal Hygiene Applications
- Skin Care Applications
Properties
- Physical Form
- Appearance
- Opalescence
- Soluble in
- Water
- Typical Properties
- Microbiological Values
| Value | Units | Test Method / Conditions | |
| Apparent Brookfield Viscosity (at 20°C, 2% in water) | 75000 - 140000 | mPa.s | Current USP/EP/JP |
| Combined Mold & Yeast ⁵ (Total Count) | max. 100 | cnt/g | Current USP |
| Heavy Metals (as Lead) | max. 20 | ppm | Current USP/EP/JP |
| Hydroxypropoxyl (Assay) | 7.0 - 12.0 | % | Current USP/EP/JP |
| Identification Tests ² | Pass | - | Current USP/EP/JP |
| Loss on Drying (as packaged) | max. 5.0 | % | Current USP/EP/JP |
| Methoxyl Content (Assay) | 19.0 - 24.0 | % | Current USP/EP/JP |
| pH (2% in Water) | 5.0 - 8.0 | - | Current USP/EP/JP |
| Residual Solvents³ | Pass | - | Current USP |
| Residue on Ignition | max. 1.5 | % | Current USP/EP/JP |
| Total Aerobic Microbial Count ⁴ | max. 100 | cnt/g | Current USP |
| Ash Content (Sulfated) | max. 1.5 | % | Current USP/EP/JP |
| Value | Units | Test Method / Conditions | |
| Staphylococcus aureus ⁶ | Absent | - | Current USP |
| Pseudomonas Aeruginosa ⁷ | Absent | - | Current USP |
| Salmonella Species ⁸ | Absent | - | Current USP |
| Escherichia Coli⁹ | Absent | - | Current USP |
Regulatory & Compliance
- Certifications & Compliance
- Chemical Inventories
- Regulatory Information
- Does not meet the definition of a nanomaterial as listed in Article 2(k) of the EU Cosmetic Regulation
- Does not contain any ingredient of animal origin
- Does not contain alcohol and no alcohol has been used in the manufacturing process (alcohol = methanol, ethanol)
- The equipment used in the manufacturing process, including packaging, is not additionally used for the manufacture or packaging of animal origin products or products containing ingredients of animal origin
- Certified that during the manufacturing, packaging, and storage of these products, these products are fully separated from foods containing ingredients of porcine origin and/or alcohol
- No animal cross contamination
- No porcine contamination
- To the best of our knowledge this product complies with California Prop 65*
- Biobased Carbon Weight % (Methocel K-Chemistry: 74%)
Technical Details & Test Data
- Notes
- Current E464 - European Parliament and Council Directive
- Current EP - European Pharmacopeia
- Current JP - Japanese Pharmacopeia
- Current USP - United States Pharmacopeia
- U.S. FDA 21 CFR 172.874
- U.S. FDA GRAS Notification GRN 000213
Final Testing Requirements Notes
- In the monograph revision provided in PhEur 5.7, the Viscosity method for products with nominal viscosities of greater than or equal to 600 mPa.s changed from a rotational viscosity measurement at a constant shear rate to a rotational viscosity measurement using a specified spindle/speed combination. While both methods provide results in units of mPa.s, the resulting viscosities for the two measurements differ due to the non-Newtonian nature of the product. Similarly, in the monograph revisions provided in USP 30 & JP 15, the method for viscosity for these same products changed from a solution viscosity measurement to a rotational viscosity measurement using a specified spindle/speed combination. As a result of this change, the unit of measure changed from cPs to mPa.s and the final viscosities for the two measurements also differ due to the non- Newtonian nature of the product. The limits for the USP/EP/JP test item have been selected to ensure equivalency in product viscosities with historical batches which were tested using the previous monograph test methods.
- Identification Tests A-E specified in the USP and EP monographs are identical to tests 1-5 specified in the JP monograph.
- Based on knowledge of the manufacturing process and controlled handling and storage, this product complies with ICH Q3C Residual Solvents Guidance requirements. The solvents listed as Class 1, 2 and by the USP/NF are not used in the manufacturing process.
- Microbiological
- Microbiological
- Microbiological
- Microbiological
- Microbiological
- Microbiological
General Notes
- Tests tagged or noted as "Audit Basis" are conducted on a frequency that is established for each test. Audit testing is justified by knowledge of the manufacturing process, process control, use of dedicated equipment and raw material specifications. For tests conducted on an audit basis, individual batch test results are not provided on the Certificate of Analysis (COA). Instead, a statement of typical properties is given.
- Tests tagged or noted as "Microbiological" are conducted on a frequency that is established for each test. Audit testing is justified by knowledge of the manufacturing process, process control, use of dedicated equipment and raw material specifications. For tests conducted on an audit basis, individual batch test results are not provided on the Certificate of Analysis (COA). Instead, a statement of typical properties is given.
- Specification limits apply to product as packaged in the original container. They do not apply if the material has been repackaged, improperly stored, or if the package has been opened in an uncontrolled environment.
- Samples returned for analysis must have been obtained under conditions which prohibit the introduction of microbial contamination. Sterile containers and sampling equipment must be used.
External Notes
- This product meets all requirements of substitution type 2208 in the current USP, EP, and JP monographs for Hypromellose.
- This product is certified Kosher for Passover and Pareve. This product also meets the specific purity criteria for the food additive Hydroxypropyl Methyl Cellulose (E 464) listed within the Official Journal of the European Union.
- This product is certified to contain not more than 0.1% of each of the following components: Propylene glycol, Dipropylene glycol, Tripropylene glycol, Dipropylene glycol monomethyl ether and Tripropylene glycol monomethyl ether.
Packaging & Availability
- Packaging Type