Pantoprazole EP Impurity D and F(USP Impurity D and F) CAS CATO-C4X-139910

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-139910
Molecular Formula2*C17H17F2N3O4S
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Pantoprazole EP Impurity D and F(USP Impurity D and F) CAS CATO-C4X-139910 chemical structure

Description

As a certified reference material (CRM), Pantoprazole EP Impurity D and F(USP Impurity D and F) meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

CATO supplies Pantoprazole EP Impurity D and F(USP Impurity D and F) (CAS CATO-C4X-139910), a pharmacopoeial impurity reference standard (molecular formula C17H17F2N3O4S, MW 397.40 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Pantoprazole EP Impurity D and F(USP Impurity D and F) (C17H17F2N3O4S) is characterized by a flavonoid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage, fluorine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.

Physical & Chemical Properties

Molecular Formula2*C17H17F2N3O4S
Molecular Weight397.40 g/mol
Purity>95%
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)10.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing
Nitrogen Atoms3
Sulfur Atoms1

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