Nizatidine EP Impurity J CAS 78441-69-7

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.78441-69-7
Molecular FormulaC7H12N2OS
Molecular Weight172.25 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Nizatidine EP Impurity J CAS 78441-69-7 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Nizatidine EP Impurity J.

As a process- or degradation-related impurity, Nizatidine EP Impurity J (CAS 78441-69-7, C7H12N2OS) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Nizatidine EP Impurity J (C7H12N2OS) contains an amide group, sulfur-containing functionality, a hydroxyl group, an ether linkage. Its physicochemical properties are representative of its class; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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.

CATO manufactures Nizatidine EP Impurity J under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular FormulaC7H12N2OS
Molecular Weight172.25 g/mol
Purity97%+
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)3.0
UV AbsorptionUV-absorbing
CAS Registry Year (est.)1979
Nitrogen Atoms2
Sulfur Atoms1

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