Tizanidine Impurity 65 CAS 67357-54-4

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.67357-54-4
Molecular FormulaC10H9ClN2O2
Molecular Weight224.64 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Tizanidine Impurity 65 CAS 67357-54-4 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 224.64 g/mol gives Tizanidine Impurity 65 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

As a process- or degradation-related impurity, Tizanidine Impurity 65 (CAS 67357-54-4, C10H9ClN2O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution, Tizanidine Impurity 65 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 224.64 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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.

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 FormulaC10H9ClN2O2
Molecular Weight224.64 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 sealed and dry, 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; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)7.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1976
Halogen ContentCl-containing
Nitrogen Atoms2

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