Palbociclib Impurity 25 CAS 1016636-76-2

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.1016636-76-2
Molecular FormulaC13H13BrClN3O
Molecular Weight342.62 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Palbociclib Impurity 25 CAS 1016636-76-2 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 Palbociclib Impurity 25.

As a process- or degradation-related impurity, Palbociclib Impurity 25 (CAS 1016636-76-2, C13H13BrClN3O) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Based on its molecular formula C13H13BrClN3O, Palbociclib Impurity 25 contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine/bromine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 342.62 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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), Palbociclib Impurity 25 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 FormulaC13H13BrClN3O
Molecular Weight342.62 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor, low volatility)
Purity97%+
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)8.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1988
Halogen ContentCl/Br-containing
Nitrogen Atoms3

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