Capecitabine Impurity 45 CAS 162204-22-0

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.162204-22-0
Molecular FormulaC19H26FN3O8
Molecular Weight443.42 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Capecitabine Impurity 45 CAS 162204-22-0 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 Capecitabine Impurity 45.

As a process- or degradation-related impurity, Capecitabine Impurity 45 (CAS 162204-22-0, C19H26FN3O8) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a flavonoid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution, Capecitabine Impurity 45 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 443.42 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

As a certified reference material (CRM), Capecitabine Impurity 45 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

Molecular FormulaC19H26FN3O8
Molecular Weight443.42 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity>95%
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)8.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2003
Halogen ContentF-containing
Nitrogen Atoms3

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