Nintedanib Impurity 129 CAS CATO-C4X-1814129

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-1814129
Molecular FormulaC16H24N4O3
Molecular Weight320.39 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Nintedanib Impurity 129 CAS CATO-C4X-1814129 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 Nintedanib Impurity 129.

Nintedanib Impurity 129 (CAS CATO-C4X-1814129) is a certified pharmaceutical impurity reference standard with the molecular formula C16H24N4O3 and a molecular weight of 320.39 g/mol.

Structurally, Nintedanib Impurity 129 (C16H24N4O3) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 7.0, corresponding to approximately 7 ring(s) or double-bond equivalent(s). With a molecular weight of 320.39 g/mol, it falls into the moderately-high-molecular-weight range. 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 Nintedanib Impurity 129 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 FormulaC16H24N4O3
Molecular Weight320.39 g/mol
AppearanceOff-white to pale yellow crystalline powder
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
Degree of Unsaturation (DBE)7.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms4

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