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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.

Nitroso Escitalopram ESTRC-1

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Catalogue No.:	VE007926
CAS No.:	N/A
Mol. Formula:	C19H18FN3O2
Mol. Weight:	339.36 g/mol

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Additional information on Nitroso Escitalopram ESTRC-1

Parent drug

Escitalopram

IUPAC Name

(R)-N-(3-(5-cyano-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-1-yl)propyl)-N-methylnitrous amide

FDA Potency Category 1 NDSRI

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

Pharmacopoeial Synonyms

N/A

Other Synonyms

N-Nitroso Desmethylcitalopram

Smiles

O=NN(CCC[C@]1(C2=CC=C(F)C=C2)OCC3=C1C=CC(C#N)=C3)C

InChI

InChI=1S/C19H18FN3O2/c1-23(22-24)10-2-9-19(16-4-6-17(20)7-5-16)18-8-3-14(12-21)11-15(18)13-25-19/h3-8,11H,2,9-10,13H2,1H3/t19-/m1/s1

Description

Nitroso-Escitalopram ESTRC-1, also designated N-Nitroso Desmethylcitalopram, is a nitrosamine impurity associated with the citalopram and escitalopram chemical space. With molecular formula C19H18FN3O2 and molecular weight 339.36 g/mol, it contains an N-nitroso functionality on the desmethylated amine scaffold. Such species may arise during nitrosation of secondary amine precursors under process or storage conditions, and they are treated under ICH M7 as potentially mutagenic, often requiring compound-specific toxicological assessment. Characterization commonly relies on LC-MS/MS with high-resolution MS confirmation, and GC-MS may be used when volatility and thermal stability permit. Quantitation typically demands stringent control of low-level contamination and matrix effects.