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2920299-23-4Riociguat EP Impurity C (Free Base)

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Catalogue No.:	VE0018399
CAS No.:	2920299-23-4
Mol. Formula:	C21H21FN8O2
Mol. Weight:	436.45 g/mol

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Additional information on CAS 2920299-23-4

Parent drug

Riociguat

IUPAC Name

Methyl [4-amino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-6-(methylamino)pyrimidin-5-yl](methyl)carbamate

Pharmacopeial Synonyms

Riociguat Related Compound C

Synonyms

Methyl (4-amino-2-(1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl)-6-(methylamino)pyrimidin-5-yl)(methyl)carbamate

Smiles

O=C(OC)N(C1=C(NC)N=C(C2=NN(CC3=CC=CC=C3F)C4=NC=CC=C42)N=C1N)C

InChI

InChI=1S/C21H21FN8O2/c1-24-19-16(29(2)21(31)32-3)17(23)26-18(27-19)15-13-8-6-10-25-20(13)30(28-15)11-12-7-4-5-9-14(12)22/h4-10H,11H2,1-3H3,(H3,23,24,26,27)

Description

Riociguat EP Impurity C, also listed as Riociguat Related Compound C and Methyl (4-amino-2-(1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl)-6-(methylamino)pyrimidin-5-yl)(methyl)carbamate, CAS 2920299-23-4, is a defined synthesis impurity monitored in riociguat drug substance quality control. Characterization data typically include retention time by HPLC, high resolution mass spectrometry confirming molecular ion, and proton and carbon NMR shifts for structural assignment. Controlled via validated analytical methods, the impurity is reported in stability studies, forced degradation profiling, and batch release specifications to support impurity profiling and specification setting. Technical documentation includes proposed identification, qualification thresholds, and analytical method suitability for regulatory submissions.