Levofloxacin Impurity 36 CAS 2130840-88-7

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.2130840-88-7
Molecular FormulaC20H23FN4O6
Molecular Weight434.42 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Levofloxacin Impurity 36 CAS 2130840-88-7 chemical structure

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Levofloxacin Impurity 36.

CATO supplies Levofloxacin Impurity 36 (CAS 2130840-88-7), a pharmacopoeial impurity reference standard (molecular formula C20H23FN4O6, MW 434.42 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Levofloxacin Impurity 36 (C20H23FN4O6) contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 11.0, corresponding to approximately 11 ring(s) or double-bond equivalent(s). With a molecular weight of 434.42 g/mol, it falls into the moderately-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.

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 FormulaC20H23FN4O6
Molecular Weight434.42 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity97%+
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; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)11.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1997
Halogen ContentF-containing
Nitrogen Atoms4

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