Nintedanib Impurity 180 CAS 2117628-65-4 (free base)

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.2117628-65-4 (free base)
Molecular FormulaC14H22N4O
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Nintedanib Impurity 180 CAS 2117628-65-4 (free base) chemical structure

Description

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution, Nintedanib Impurity 180 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 298.81 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

As a process- or degradation-related impurity, Nintedanib Impurity 180 (CAS 2117628-65-4 (free base), C14H22N4OHCl) 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), Nintedanib Impurity 180 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 FormulaC14H22N4O HCl
Molecular Weight298.81 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor)
Purity97%+
StorageStore at 2-8°C, protect from light, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms4

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