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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.

102625-64-9Pantoprazole EP Impurity B

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Catalogue No.:	VL125002
CAS No.:	102625-64-9
Mol. Formula:	C16H15F2N3O3S
Mol. Weight:	367.37 g/mol

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Additional information on CAS 102625-64-9

Parent drug

Pantoprazole

Characterization Data (Included)

HPLC, MASS/LC-MS, 1H NMR, FT-IR, Potency, and Structure Elucidation Report (SER).

Additional Characterization Data

QNMR, D2O Exchange, 13C NMR, 13C APT, COSY NMR, NOESY NMR, 15N NMR, HSQC NMR, HMQC NMR, and HMBC NMR. These are available upon request and may be free or subject to additional charges.

IUPAC Name

5-(Difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]thio]-1H-benzimidazole

Pharmacopeial Synonyms

Pantoprazole Related Compound B

Synonyms

Pantoprazole sulfide; Pantoprazole thioether; 1H-Benzimidazole,5-(difluoromethoxy)-2-{[(3,4-dimethoxypyridin-2-yl)methyl]sulfanyl}-1H-1,3-benzodiazole

Smiles

COC1=C(OC)C(CSC2=NC3=CC(OC(F)F)=CC=C3N2)=NC=C1

InChI

InChI=1S/C16H15F2N3O3S/c1-22-13-5-6-19-12(14(13)23-2)8-25-16-20-10-4-3-9(24-15(17)18)7-11(10)21-16/h3-7,15H,8H2,1-2H3,(H,20,21)

Shipping Condition

Ambient Temperature

Description

Pantoprazole EP Impurity B, also designated Pantoprazole Related Compound B and Pantoprazole sulfide, CAS 102625-64-9, is the thioether precursor of pantoprazole formed by oxidation state reduction at the benzimidazole sulfur center. Its molecular formula is C16H15F2N3O3S and molecular weight is 367.37 g/mol. Structurally, it represents a process-related synthetic byproduct rather than a classical degradation product, and its presence is typically monitored as a route-specific impurity in drug substance control. Quantification generally requires reversed-phase LC-MS/MS, with LC-UV and, where necessary, high-resolution MS or impurity profiling by GC-MS to distinguish it from sulfoxide analogues and related heteroaryl sulfides.

References

Reddy, Ganta Madhusudhan, et al. “Structural Identification and Characterization of Potential Impurities of Pantoprazole Sodium.” Journal of Pharmaceutical and Biomedical Analysis, vol. 45, no. 2, Oct. 2007, pp. 201–10, https://doi.org/10.1016/j.jpba.2007.05.032. ?