Nintedanib Impurity 44 CAS 3395-80-0

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.3395-80-0
Molecular FormulaC9H11ClO2
Molecular Weight186.64 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Nintedanib Impurity 44 CAS 3395-80-0 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 44.

Nintedanib Impurity 44 (CAS 3395-80-0) is a certified pharmaceutical impurity reference standard with the molecular formula C9H11ClO2 and a molecular weight of 186.64 g/mol.

Structurally, Nintedanib Impurity 44 (C9H11ClO2) contains a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution, an aromatic ring system. The molecule exhibits a degree of unsaturation (DBE) of 4.0, corresponding to approximately 4 ring(s) or double-bond equivalent(s). With a molecular weight of 186.64 g/mol, it falls into the medium-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).

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

Molecular FormulaC9H11ClO2
Molecular Weight186.64 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor)
Purity97%+
StorageStore at 2-8°C, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure; 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.)1957
Halogen ContentCl-containing

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