Nemonoxacin impurity 103 CAS 221221-13-2

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.221221-13-2
Molecular FormulaC16H17F2NO4
Molecular Weight325.31 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Nemonoxacin impurity 103 CAS 221221-13-2 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 Nemonoxacin impurity 103.

CATO supplies Nemonoxacin impurity 103 (CAS 221221-13-2), a pharmacopoeial impurity reference standard (molecular formula C16H17F2NO4, MW 325.31 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Nemonoxacin impurity 103 (C16H17F2NO4) is characterized by a flavonoid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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.

CATO manufactures Nemonoxacin impurity 103 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular FormulaC16H17F2NO4
Molecular Weight325.31 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
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; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)8.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2020
Halogen ContentF-containing
Nitrogen Atoms1

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