1A03480

Bosentan Bis4(Tert-Butylbenzenesulfonamide)

Pharmaceutical Analytical Impurity (PAI)

• Sinónimos: Bosentan Bis4(Tert-Butylbenzenesulfonamide), (N,N′-(5-(2-METHOXYPHENOXY)-[2,2′-BIPYRIMIDINE]-4,6-DIYL)BIS(4-(TERT-BUTYL)BENZENESULFONAMIDE))
• Fórmula empírica (notación de Hill): C₃₅H₃₈N₆O₆S₂
• Número CAS: 1218951-81-5
• Peso molecular: 702.84
• MDL number: MFCD00189451
• NACRES: NA.24
• UNSPSC Code: 41116107

Propiedades

• grade: pharmaceutical analytical impurity (PAI)
• agency: USP
• API family: bosentan
• manufacturer/tradename: USP
• application(s): pharmaceutical; pharmaceutical; pharmaceutical small molecule
• format: neat
• storage temp.: 2-8°C

Descripción

General description

Find answers to frequently asked questions on USP products in USP FAQs.

Bosentan Bis4(tertbutylbenzenesulfonamide) is a USP Pharmaceutical Analytical Impurity (PAI).


USP PAI are a product line of impurities suitable for research and analytical purposes, which help to ensure the quality and safety of medicines.


Associated Drug Substance: Bosentan


Therapeutic Area: Pulmonary

Application

Bosentan Bis4(tertbutylbenzenesulfonamide) (USP PAI) is intended for use in analytical testing to detect, identify, and measure pharmaceutical impurities.

Features and Benefits

USP PAI advance your early analytical R&D and process development. PAI can be used in the following applications:
1. Conduct analytical tests during early formulation feasibility studies.
2. Determine degradation impurities produced during stress studies.
3. Develop, validate, and transfer analytical methods.
4. Perform spiking studies during process R&D to demonstrate depletion upon recrystallization.
5. Record retention times and/or spectra
6. Determine relative response factors.
7. Identify unknown impurities that formed during ICH stability conditions.
8. Identify impurities that are present in the Reference Listed Drug
9. Test for and profile impurities not listed in drug substance and drug product monographs.

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.

USP issued SDS can be found here

Información de seguridad

• Códigos de peligro: H412
• Indicaciones de precaución: P273 - P501
• Hazard Classifications: Aquatic Chronic 3
• Clase de almacenamiento: 11 - Combustible Solids
• ¿Qué está pasando?: WGK 3
• Punto de inflamación (°F): Not applicable
• Punto de inflamación (°C): Not applicable