1A04380

ETEKSYLAN N-NITROZO DABIGATRANU

Pharmaceutical Analytical Impurity (PAI)

• Synonim(y): N-nitroso dabigatran etexilate, (Ethyl 3-(2-(((4-(N-((hexyloxy)carbonyl)carbamimidoyl)phenyl)(nitroso)amino)methyl)-1-methyl-N-(pyridin-2-yl)-1H-benzo[d]imidazole-5 carboxamido)propanoate)
• Wzór empiryczny (zapis Hilla): C₃₄H₄₀N₈O₆
• Numer CAS: 2892260-29-4
• Masa cząsteczkowa: 656.73
• NACRES: NA.24
• UNSPSC Code: 41116107
• eCl@ss: 25140904

Właściwości

• grade: pharmaceutical analytical impurity (PAI)
• agency: USP
• API family: dabigatran
• manufacturer/tradename: USP
• application(s): pharmaceutical; pharmaceutical; pharmaceutical small molecule
• format: neat
• storage temp.: -10 to -25°C

Opis

General description

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

N-Nitroso dabigatran etexilate 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: Dabigatran

Application

N-Nitroso dabigatran etexilate 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

Produkty te są przeznaczone wyłącznie do testów i oznaczeń. Nie są one przeznaczone do podawania ludziom lub zwierzętom i nie mogą być stosowane do diagnozowania, leczenia lub wyleczenia jakichkolwiek chorób.

Other Notes

Sales restrictions may apply.

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Informacja o środkach bezpieczeństwa

• Klasa składowania: 11 - Combustible Solids
• Temperatura zapłonu (°F): Not applicable
• Temperatura zapłonu (°C): Not applicable