Vincristine EP Impurity H CAS 865-21-4

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.865-21-4
Molecular FormulaC46H58N4O9
Molecular Weight810.97 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Vincristine EP Impurity H CAS 865-21-4 chemical structure

Description

As a certified reference material (CRM), Vincristine EP Impurity H 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.

Vincristine EP Impurity H (CAS 865-21-4) is a certified pharmaceutical impurity reference standard with the molecular formula C46H58N4O9 and a molecular weight of 810.97 g/mol.

Structurally, Vincristine EP Impurity H (C46H58N4O9) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 20.0, corresponding to approximately 20 ring(s) or double-bond equivalent(s). With a molecular weight of 810.97 g/mol, it falls into the high-molecular-weight range. 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.

Physical & Chemical Properties

Molecular FormulaC46H58N4O9
Molecular Weight810.97 g/mol
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
Degree of Unsaturation (DBE)20.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1957
Nitrogen Atoms4

Related Vincristine Standards

Recommended Standards

Why CATO?