Alendronic Acid Impurity 5 CAS CATO-C4X-22425

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-22425
Molecular FormulaC19H20NO6P
Molecular Weight389.34 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Alendronic Acid Impurity 5 CAS CATO-C4X-22425 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 389.34 g/mol gives Alendronic Acid Impurity 5 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

As a process- or degradation-related impurity, Alendronic Acid Impurity 5 (CAS CATO-C4X-22425, C19H20NO6P) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Based on its molecular formula C19H20NO6P, Alendronic Acid Impurity 5 contains a flavonoid core, an amide group, a phosphate ester group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 389.34 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.

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 FormulaC19H20NO6P
Molecular Weight389.34 g/mol
AppearancePale yellow to yellow crystalline powder
Purity97%+
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)10.5
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms1

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