利福特尼唑杂质7 CAS CATO-C4X-34247

Purity 95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-34247
Molecular FormulaC48H59N7O13
Molecular Weight942.02 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

利福特尼唑杂质7 CAS CATO-C4X-34247 chemical structure

Description

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.

As a process- or degradation-related impurity, 利福特尼唑杂质7 (CAS CATO-C4X-34247, C48H59N7O13) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Structurally, 利福特尼唑杂质7 (C48H59N7O13) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 23.0, corresponding to approximately 23 ring(s) or double-bond equivalent(s). With a molecular weight of 942.02 g/mol, it falls into the high-molecular-weight range. 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 FormulaC48H59N7O13
Molecular Weight942.02 g/mol
Purity95%
StorageStore in a cool place (≤25°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)23.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms7

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