Lansoprazole Impurity 29 CAS 163119-28-6

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.163119-28-6
Molecular FormulaC9H9ClF3NO2
Molecular Weight255.62 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Lansoprazole Impurity 29 CAS 163119-28-6 chemical structure

Description

The molecular framework of Lansoprazole Impurity 29 (C9H9ClF3NO2) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine/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. 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).

As a process- or degradation-related impurity, Lansoprazole Impurity 29 (CAS 163119-28-6, C9H9ClF3NO2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

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 certified reference material (CRM), Lansoprazole Impurity 29 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 FormulaC9H9ClF3NO2
Molecular Weight255.62 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor, faint amine-like odor, low volatility)
Purity>95%
StorageStore at 2-8°C, protect from light, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)4.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2003
Halogen ContentF/Cl-containing
Nitrogen Atoms1

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