Posaconazole Impurity 8 CAS CATO-C4X-12088

Purity >80%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-12088
Molecular FormulaC13H20N2O2
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Posaconazole Impurity 8 CAS CATO-C4X-12088 chemical structure

Description

As a certified reference material (CRM), Posaconazole Impurity 8 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.

As a process- or degradation-related impurity, Posaconazole Impurity 8 (CAS CATO-C4X-12088, C13H20N2O2C2H2O4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Based on its molecular formula C13H20N2O2C2H2O4, Posaconazole Impurity 8 contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 326.35 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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.

Physical & Chemical Properties

Molecular FormulaC13H20N2O2 C2H2O4
Molecular Weight326.35 g/mol
AppearanceOff-white to pale yellow crystalline powder
Purity>80%
StorageStore at 2-8°C, protect from light, keep sealed and dry
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
Degree of Unsaturation (DBE)6.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms2

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