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Documentation

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

N-Nitroso Edoxaban Tosylate Monohydrate

● Under Development

Catalogue No.:	VE0010431
CAS No.:	N/A
Mol. Formula:	C30H35ClN8O8S2
Mol. Weight:	735.23 g/mol

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Additional information on N-Nitroso Edoxaban Tosylate Monohydrate

Parent drug

Edoxaban

IUPAC Name

N1-(5-chloropyridin-2-yl)-N2-((1S, 2R, 4S)-4-(dimethylcarbamoyl)-2-(5-nitroso-4, 5, 6, 7-tetrahydrothiazolo[5, 4-c]pyridine-2-carboxamido)cyclohexyl)oxalamide 4-methylbenzenesulfonate

Pharmacopoeial Synonyms

N/A

Other Synonyms

3-Pyridinecarboxylic Acid; 3-Carboxylpyridine; 3-Carboxypyridine

Smiles

O=C(NC1=NC=C(Cl)C=C1)C(N[C@@H]2[C@H](NC(C(S3)=NC4=C3CN(N=O)CC4)=O)C[C@@H](C(N(C)C)=O)CC2)=O.O=S(C5=CC=C(C)C=C5)(O)=O

InChI

InChI=1S/C23H27ClN8O5S.C7H8O3S/c1-31(2)23(36)12-3-5-14(26-19(33)20(34)29-18-6-4-13(24)10-25-18)16(9-12)27-21(35)22-28-15-7-8-32(30-37)11-17(15)38-22;1-6-2-4-7(5-3-6)11(8,9)10/h4,6,10,12,14,16H,3,5,7-9,11H2,1-2H3,(H,26,33)(H,27,35)(H,25,29,34);2-5H,1H3,(H,8,9,10)/t12-,14-,16+;/m0./s1

Description

N-Nitroso Edoxaban Tosylate Monohydrate is an N-nitroso derivative of the secondary amine present in Edoxaban | 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 Edoxaban 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.