Varenicline Impurity 45 CAS 230615-05-1

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.230615-05-1
Molecular FormulaC11H14N2
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Varenicline Impurity 45 CAS 230615-05-1 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.

As a process- or degradation-related impurity, Varenicline Impurity 45 (CAS 230615-05-1, C11H14N2HCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a nitrogen-containing heterocyclic scaffold, a nitrile group, chlorine substitution, Varenicline Impurity 45 is typically off-white to pale yellow low-melting solid. Its solid-state physicochemical attributes — including a molecular weight of 210.70 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).

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 FormulaC11H14N2 HCl
Molecular Weight210.70 g/mol
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
CAS Registry Year (est.)2022
Halogen ContentCl-containing
Nitrogen Atoms2

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