Valsartan Impurity 80 TriHCl CAS CATO-C4X-105780

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-105780
Molecular FormulaC33H31N9O2
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Valsartan Impurity 80 TriHCl CAS CATO-C4X-105780 chemical structure

Description

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.

As a process- or degradation-related impurity, Valsartan Impurity 80 TriHCl (CAS CATO-C4X-105780, C33H31N9O2HCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

The molecular framework of Valsartan Impurity 80 TriHCl (C33H31N9O2HCl) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine 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. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

As a certified reference material (CRM), Valsartan Impurity 80 TriHCl 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.

Physical & Chemical Properties

Molecular FormulaC33H31N9O2 3*HCl
Molecular Weight622.13 g/mol
Purity>95%
StorageStore in a cool place (≤25°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)22.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms9

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