Pantoprazole Impurity D & F Mixture
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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.

Pantoprazole Impurity D & F Mixture

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Catalogue No.:VL125004
CAS No.:N/A
Mol. Formula:C34H34F4N6O8S2
Mol. Weight:794.79 g/mol

Additional information on Pantoprazole Impurity D & F Mixture

Parent drug

Pantoprazole

IUPAC Name

5-(difluoromethoxy)-2-(((3,4-dimethoxypyridin-2-yl)methyl)sulfinyl)-1-methyl-1H-benzo[d]imidazole compound with 6-(difluoromethoxy)-2-(((3,4-dimethoxypyridin-2-yl)methyl)sulfinyl)-1-methyl-1H-benzo[d]imidazole (1:1)

Pharmacopeial Synonyms

N/A

Other Synonyms

N/A

Smiles

CN1C(S(CC2=NC=CC(OC)=C2OC)=O)=NC3=CC(OC(F)F)=CC=C13.CN4C(S(CC5=NC=CC(OC)=C5OC)=O)=NC6=CC=C(OC(F)F)C=C46

InChI

InChI=1S/2C17H17F2N3O4S/c1-22-13-5-4-10(26-16(18)19)8-11(13)21-17(22)27(23)9-12-15(25-3)14(24-2)6-7-20-12;1-22-13-8-10(26-16(18)19)4-5-11(13)21-17(22)27(23)9-12-15(25-3)14(24-2)6-7-20-12/h2*4-8,16H,9H2,1-3H3

Description

The Pantoprazole Impurity D & F Mixture standard is a well-characterized compound that aligns with key regulatory guidelines, including USP, EMA, JP, and BP. It plays a crucial role in analytical method development, method validation (AMV), and quality control (QC) processes, particularly in the manufacturing of Pantoprazole. This impurity standard is valuable for both Abbreviated New Drug Applications (ANDA) and New Drug Applications (NDA), ensuring reliable and precise analytical outcomes. Pantoprazole is a proton pump inhibitor, used to treat ulcers, gastroesophageal reflux disorder, erosive esophagitis, and Zollinger-Ellison syndrome.

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