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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.

2476859-55-7N-Nitroso Ticagrelor

● Failure Report (NAP Test) Available

Catalogue No.:	VE008489
CAS No.:	2476859-55-7
Mol. Formula:	C23H27F2N7O5S
Mol. Weight:	551.6 g/mol

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Additional information on CAS 2476859-55-7

FDA Potency Category 5 NDSRI

1500 ng/day is the U.S. FDA’s current Acceptable Intake (AI) limit for N-nitroso-ticagrelor (NDSRI). Refer to the FDA nitrosamine page for the latest guidance.

Parent drug

Ticagrelor

IUPAC Name

N-((1R, 2S)-2-(3, 4-difluorophenyl)cyclopropyl)-N-(3-((1R, 2S, 3S, 4S)-2, 3-dihydroxy-4-(2-hydroxyethoxy)cyclopentyl)-5-(propylthio)-3H-[1, 2, 3]triazolo[4, 5-d]pyrimidin-7-yl)nitrous amide

Pharmacopoeial Synonyms

Ticagrelor Nitroso Impurity

Other Synonyms

(1S,2S,3R,5S)-3-[7-[[(1R,2S)-2-(3,4-Difluorophenyl)cyclopropyl]nitrosoamino]-5-(propylthio)-3H-1,2,3-triazolo[4,5-d]pyrimidin-3-yl]-5-(2-hydroxyethoxy)-1,2-cyclopentanediol; 1,2-Cyclopentanediol, 3-[7-[[(1R,2S)-2-(3,4-difluorophenyl)cyclopropyl]nitrosoamino]-5-(propylthio)-3H-1,2,3-triazolo[4,5-d]pyrimidin-3-yl]-5-(2-hydroxyethoxy)-, (1S,2S,3R,5S)

Smiles

O=NN([C@H]1[C@H](C2=CC=C(F)C(F)=C2)C1)C3=C(N=NN4[C@H]5[C@H](O)[C@H](O)[C@@H](OCCO)C5)C4=NC(SCCC)=N3

InChI

InChI=1S/C23H27F2N7O5S/c1-2-7-38-23-26-21-18(28-29-31(21)16-10-17(37-6-5-33)20(35)19(16)34)22(27-23)32(30-36)15-9-12(15)11-3-4-13(24)14(25)8-11/h3-4,8,12,15-17,19-20,33-35H,2,5-7,9-10H2,1H3/t12-,15+,16+,17-,19-,20+/m0/s1

Description

N-Nitroso Ticagrelor is an N-nitroso derivative of the secondary amine present in Ticagrelor | 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 Ticagrelor 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.

N-Nitroso Ticagrelor: Synthesis Attempts and Failure Report (NAP Test)