Betacarotene EP Impurity D CAS 13312-52-2

Purity Technical GradeIn StockPharmacopoeial Impurity Standards
CAS No.13312-52-2
Molecular FormulaC40H56
Molecular Weight536.87 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Betacarotene EP Impurity D CAS 13312-52-2 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 Betacarotene EP Impurity D.

CATO supplies Betacarotene EP Impurity D (CAS 13312-52-2), a pharmacopoeial impurity reference standard (molecular formula C40H56, MW 536.87 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Betacarotene EP Impurity D (C40H56) is characterized by a polycyclic aromatic system. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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.

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

Physical & Chemical Properties

Molecular FormulaC40H56
Molecular Weight536.87 g/mol
AppearancePale yellow to yellow crystalline powder
PurityTechnical Grade
StorageStore at room temperature, protect from light
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)13.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1960

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