Sunitinib Impurity 63 CAS 2343-22-8

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.2343-22-8
Molecular FormulaC8H8FN
Molecular Weight137.15 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Sunitinib Impurity 63 CAS 2343-22-8 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 Sunitinib Impurity 63.

Sunitinib Impurity 63 (CAS 2343-22-8) is a certified pharmaceutical impurity reference standard with the molecular formula C8H8FN and a molecular weight of 137.15 g/mol.

Owing to a nitrogen-containing heterocyclic scaffold, a nitrile group, fluorine substitution, Sunitinib Impurity 63 is typically off-white to pale yellow liquid. Its solid-state physicochemical attributes — including a molecular weight of 137.15 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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.

As a certified reference material (CRM), Sunitinib Impurity 63 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 FormulaC8H8FN
Molecular Weight137.15 g/mol
Purity>95%
StorageStore at 2-8°C, protect from light, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in methanol, acetonitrile, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1957
Halogen ContentF-containing
Nitrogen Atoms1

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