All-Rac-Phytomenadione EP Impurity B CAS 25486-55-9

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.25486-55-9
Molecular FormulaC31H46O3
Molecular Weight466.70 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

All-Rac-Phytomenadione EP Impurity B CAS 25486-55-9 chemical structure

Description

The occurrence of All-Rac-Phytomenadione EP Impurity B is closely related to a carboxylic acid group, a hydroxyl group, an ether linkage, a polycyclic aromatic system in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies All-Rac-Phytomenadione EP Impurity B (CAS 25486-55-9), a pharmacopoeial impurity reference standard (molecular formula C31H46O3, MW 466.70 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, All-Rac-Phytomenadione EP Impurity B (C31H46O3) contains a carboxylic acid group, a hydroxyl group, an ether linkage, a polycyclic aromatic system. The molecule exhibits a degree of unsaturation (DBE) of 9.0, corresponding to approximately 9 ring(s) or double-bond equivalent(s). With a molecular weight of 466.70 g/mol, it falls into the moderately-high-molecular-weight range. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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), All-Rac-Phytomenadione EP Impurity B 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 FormulaC31H46O3
Molecular Weight466.70 g/mol
AppearancePale yellow to yellow crystalline powder
Purity>90%
StorageStore at room temperature, protect from light, keep sealed and dry
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1964

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