Nintedanib Impurity 64 CAS 855860-75-2

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.855860-75-2
Molecular FormulaC9H11ClN2O
Molecular Weight198.65 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Nintedanib Impurity 64 CAS 855860-75-2 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.

Nintedanib Impurity 64 (CAS 855860-75-2) is a certified pharmaceutical impurity reference standard with the molecular formula C9H11ClN2O and a molecular weight of 198.65 g/mol.

Structurally, Nintedanib Impurity 64 (C9H11ClN2O) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 5.0, corresponding to approximately 5 ring(s) or double-bond equivalent(s). With a molecular weight of 198.65 g/mol, it falls into the medium-molecular-weight range. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

As a certified reference material (CRM), Nintedanib Impurity 64 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 FormulaC9H11ClN2O
Molecular Weight198.65 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor, faint amine-like odor)
Purity>95%
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
CAS Registry Year (est.)1987
Halogen ContentCl-containing
Nitrogen Atoms2

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