Mizolastine Impurity 5 CAS 130212-30-5

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.130212-30-5
Molecular FormulaC10H16N4O
Molecular Weight208.26 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Mizolastine Impurity 5 CAS 130212-30-5 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 208.26 g/mol gives Mizolastine Impurity 5 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

As a process- or degradation-related impurity, Mizolastine Impurity 5 (CAS 130212-30-5, C10H16N4O) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Mizolastine Impurity 5 (C10H16N4O) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. Its physicochemical properties are representative of its class; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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.

As a certified reference material (CRM), Mizolastine Impurity 5 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 FormulaC10H16N4O
Molecular Weight208.26 g/mol
AppearanceOff-white to pale yellow crystalline powder. (faint amine-like odor)
Purity97%+
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1994
Nitrogen Atoms4

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