Stock Locations

New Jersey, USA
Czech Republic, EU
Mumbai, India

* Stock subject to availability.

Documentation

Download MSDS

Download Sample COA

Includes: HPLC, MASS/LC-MS, 1H NMR, FT-IR, Potency, Structure Elucidation Report (SER), and additional analytical data depending on the product.

N-Nitroso Dabigatran Impurity 8

● In Stock

Catalogue No.:	VE0014043
CAS No.:	N/A
Mol. Formula:	C34H39N7O7
Mol. Weight:	657.73 g/mol

Request a quote

Add to RFQ list

Additional information on N-Nitroso Dabigatran Impurity 8

Parent drug

Dabigatran

IUPAC Name

ethyl 3-(2-(((4-(((hexyloxy)carbonyl)carbamoyl)phenyl)(nitroso)amino) methyl)-1-methyl-N-(pyridin-2-yl)-1H-benzo[d]imidazole-5-carboxamido)propanoate

Pharmacopoeial Synonyms

N/A

Smiles

O=C(OCC)CCN(C1=NC=CC=C1)C(C2=CC=C3N(C)C(CN(C4=CC=C(C(NC(OCCCCCC)=O)=O)C=C4)N=O)=NC3=C2)=O

InChl

InChI=1S/C34H39N7O7/c1-4-6-7-10-21-48-34(45)37-32(43)24-12-15-26(16-13-24)41(38-46)23-30-36-27-22-25(14-17-28(27)39(30)3)33(44)40(20-18-31(42)47-5-2)29-11-8-9-19-35-29/h8-9,11-17,19,22H,4-7,10,18,20-21,23H2,1-3H3,(H,37,43,45)

Other Synonyms

N/A

Description

N-Nitroso Dabigatran Impurity 8 is an N-nitroso derivative of the secondary amine present in Dabigatran | which is a highly characterized reference material that meets stringent regulatory standards set for nitrosamine compounds | including those set by USP | EMA | JP | and BP. This nitroso standard is essential for a variety of applications | such as analytical method development | method validation (AMV) | and Quality Control (QC) | particularly in the context of Dabigatran production. It is suitable for use in both Abbreviated New Drug Applications (ANDA) and New Drug Applications (NDA). This nitrosamine standard helps establish detection limits | quantify impurity levels | and ensure trace nitroso impurities in pharmaceutical products remain within FDA and EMA safety limits.