Rifapentine Impurity 11 CAS CATO-C4X-195911

Purity ≥96%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-195911
Molecular FormulaC46H62N4O12
Molecular Weight863.00 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Rifapentine Impurity 11 CAS CATO-C4X-195911 chemical structure

Description

CATO supplies Rifapentine Impurity 11 (CAS CATO-C4X-195911), a pharmacopoeial impurity reference standard (molecular formula C46H62N4O12, MW 863.00 g/mol) used for the identification and quantification of trace impurities in APIs.

Rifapentine Impurity 11 (C46H62N4O12) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. It is notably hygroscopic, the carboxyl group imparts weak acidity; 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.

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 FormulaC46H62N4O12
Molecular Weight863.00 g/mol
Purity≥96%
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)18.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms4

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