Palbociclib Impurity 77 0.7HCl 0.3HCOOH CAS 2204863-06-7(free base)

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.2204863-06-7(free base)
Molecular FormulaC24H29N7O
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Palbociclib Impurity 77 0.7HCl 0.3HCOOH CAS 2204863-06-7(free base) chemical structure

Description

As a certified reference material (CRM), Palbociclib Impurity 77 0.7HCl 0.3HCOOH 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.

As a process- or degradation-related impurity, Palbociclib Impurity 77 0.7HCl 0.3HCOOH (CAS 2204863-06-7(free base), C24H29N7O0.(C2H4O2)0.(HCl)) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

The molecular framework of Palbociclib Impurity 77 0.7HCl 0.3HCOOH (C24H29N7O0.(C2H4O2)0.(HCl)) is characterized by a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine 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. 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.

Physical & Chemical Properties

Molecular FormulaC24H29N7O 0.3*(C2H4O2) 0.7*(HCl)
Molecular Weight528.05 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)13.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms7

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