Plastic additive 11
USP/1545023 - United States Pharmacopeia (USP) Reference Standard
Synonym: Poly(4-
CAS Number: 65447-77-0
MDL Number: MFCD02688598
Linear Formula: (C15H29NO6)n
Product Type: Chemical
| application(s) | USP Biologics pharmaceutical (small molecule) |
| form | powder |
| format | neat |
| grade | pharmaceutical primary standard |
| InChI | 1S/C17H31NO4/c1-13(19)7-8 |
| InChI key | CTJXKCPBMVLOQI-UHFFFAOYSA |
| manufacturer/tradename | USP |
| mp | >350 °C (lit.) |
| SMILES string | N1(C(CC(CC1(C)C)OC)(C)C)C |
| Analysis Note: | These products are for test and assay use only. They are not meant for administration to humans or animals and cannot be used to diagnose, treat, or cure diseases of any kind. |
| Application: | Plastic additive 11 USP reference standard, intended for use in specified quality tests and assays as specified in the USP compendia. |
| General description: | Plastic additive 11 is used to ensure the flexibility and strength of polymeric materials used in biologic formulations. It is a key excipient in biologics packaging, contributing to the longevity and stability of biologic drugs. By meeting USP reference standards, this additive ensures that biologics maintain their therapeutic efficacy throughout their shelf life. The United States Pharmacopeia (USP) provides quality standards for biologics to ensure their safety, efficacy, and quality throughout the manufacturing process. These standards assist manufacturers in adhering to regulatory requirements and help safeguard public health by reducing risks associated with biologics. |
| General description: | This product is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including SDS and any product information leaflets have been developed and issued under the Authority of the issuing Pharmacopoeia. For further information and support please go to the website of the issuing Pharmacopoeia ![]() |
| Other Notes: | Sales restrictions may apply. |
| Other Notes: | This product is part of USP Biologics Program. |
| Other Notes: | This product is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including SDS and any product information leaflets have been developed and issued under the Authority of the issuing Pha |
| Other Notes: | This product is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including SDS and any product information leaflets have been developed and issued under the Authority of the issuing Pharmacopoeia. For further information and support please go to the website of the issuing Pharmacopoeia ![]() |
| RIDADR | NONH for all modes of transport |
| WGK Germany | WGK 1 |
| Flash Point(F) | 428.0 °F - closed cup |
| Flash Point(C) | 220 °C - closed cup |
| mp | >350 °C (lit.) |
| UNSPSC | 41116107 |

