1601180

Lösungsmittelrückstände Klasse 1 - 1,2-Dichlorethan

United States Pharmacopeia (USP) Reference Standard

• Synonym(e): 1,2–Dichlorethan -Lösung, 1,2-Dichlorethan in Dimethylsulfoxid
• Empirische Formel (Hill-System): C₂H₄Cl₂
• CAS-Nummer: 107-06-2
• Molekulargewicht: 98.96
• MDL number: MFCD00000963
• UNSPSC Code: 41116107
• NACRES: NA.24

Eigenschaften

• grade: pharmaceutical primary standard
• agency: USP
• form: liquid
• manufacturer/tradename: USP
• application(s): USP Biologics; pharmaceutical (small molecule)
• format: neat
• storage temp.: 2-8°C
• SMILES string: ClCCCl
• InChI: 1S/C2H4Cl2/c3-1-2-4/h1-2H2
• InChI key: WSLDOOZREJYCGB-UHFFFAOYSA-N

Beschreibung

General description

1,2-Dichloroethane is a Class 1 residual solvent with known carcinogenic properties. As a USP reference standard, its presence in biologic products is strictly regulated to ensure that residual amounts remain within safe limits. Its detection is crucial for ensuring the safety of biologic products, as it can adversely affect patient health if present in excessive quantities.

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.

This compound is listed in the SVHC (Substances of very high concern) candidate list of ECHA (European Chemicals Agency)

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.

Application

Residual Solvent Class 1 - 1,2-Dichloroethane USP reference standard, intended for use in specified quality tests and assays as specified in the USP compendia.

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.  ​

Other Notes

Sales restrictions may apply.

This compound is listed in the SVHC (Substances of very high concern) candidate list of ECHA (European Chemicals Agency)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.

This product is part of USP Biologics Program.

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

Sicherheitshinweise

• pictograms: GHS08
• signalword: Danger
• hcodes: H350
• pcodes: P201 - P202 - P280 - P308 + P313 - P405 - P501
• Hazard Classifications: Carc. 1B
• Lagerklasse: 6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
• wgk: WGK 3
• flash_point_f: 188.6 °F
• flash_point_c: 87.00 °C