N-Nitroso Pantoprazole EP Impurity A

● Under Development

Catalogue No.:	VE0013068
CAS No.:	N/A
Mol. Formula:	C16H14F2N4O6S
Mol. Weight:	428.4 g/mol

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Additional information on N-Nitroso Pantoprazole EP Impurity A

Parent drug

Pantoprazole

IUPAC Name

5-(difluoromethoxy)-2-(((3, 4-dimethoxypyridin-2-yl)methyl)sulfonyl)-1-nitroso-1H-benzo[d]imidazole

Pharmacopoeial Synonyms

N/A

Other Synonyms

N/A

Smiles

O=NN1C(S(=O)(CC2=NC=CC(OC)=C2OC)=O)=NC3=CC(OC(F)F)=CC=C13

InChl

InChI=1S/C16H14F2N4O6S/c1-26-13-5-6-19-11(14(13)27-2)8-29(24,25)16-20-10-7-9(28-15(17)18)3-4-12(10)22(16)21-23/h3-7,15H,8H2,1-2H3InChI=1S/C16H14F2N4O6S/c1-26-13-5-6-19-11(14(13)27-2)8-29(24,25)16-20-10-7-9(28-15(17)18)3-4-12(10)22(16)21-23/h3-7,15H,8H2,1-2H3InChI=1S/C16H14F2N4O6S/c1-26-13-5-6-19-11(14(13)27-2)8-29(24,25)16-20-10-7-9(28-15(17)18)3-4-12(10)22(16)21-23/h3-7,15H,8H2,1-2H3

Description

N-Nitroso Pantoprazole EP Impurity A is an N-nitroso derivative of the secondary amine present in Pantoprazole | 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 Pantoprazole 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.