| Materials | PC PC Silicone Colorant PC |
| Manufacturing Environment Classification | Controlled but not formally classified |
| Colorant in Part | Yes |
| Regrind Used to Manufacture This Part | No |
| Hazardous Goods | No |
| Product Shelf Life Non-Irradiation (months) | 36 |
| Animal Derived Ingredients (BSE/TSE) | Certified Animal Derived Component Free (ADCF) |
| California Prop. 65 | SOME Substances on the California Proposition 65 list have been knowingly or intentionally added |
| California Prop. 65 List Date | 12/29/2023 12:00:00 am |
| European Pharmacopoeia (EP) 3.1.X | Information Not Available |
| Human Derived Ingredients | Does NOT intentionally contain human derived ingredients |
| Latex | Does NOT intentionally contain natural latex |
| Nanomaterials | Does NOT intentionally contain nanomaterials |
| PFAS | Does NOT intentionally contain PFAS |
| REACH SVHC | No Substance(s) Present Above Threshold |
| REACH SVHC Candidate List | 2023 June 14 (235 Substances) |
| RoHS3 (2015/863) | Conforms to requirements of RoHS 2015/863 (RoHS3) |
| EtO Compatible | Yes |
| Gamma Compatible | Yes |
| Residual Solvents: Tested via ICH Q3C Standard | No ICH Q3C Testing Performed |
| Elemental Impurities: Tested via ICH Q3D Standard | No ICH Q3D Testing Performed |
| Protein Absorption Data Available | No |
| Extractables Testing Claims | No Extractables Testing Performed |
| Visible-Subvisible Particulate Claim | Information Not Available |
| Bioburden USP 61 62 | No bioburden information available |
| Tested via USP 661.1 | No |
| Integrity Tested? | No |
The products in our inventory are intended solely for use as components for further manufacturing, processing or incorporation into a finished device. These products are not intended for use as finished devices. Customers are solely responsible for determining whether a Qosina component product is appropriate for customer’s intended use and for ensuring that the use of the component product is in compliance with applicable laws. Our components are not available for sale to hospitals, physicians, and pharmacists.
