Bedaquiline Impurity 8 CAS 2122862-01-3

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.2122862-01-3
Molecular FormulaC32H32N2O2
Molecular Weight476.61 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Bedaquiline Impurity 8 CAS 2122862-01-3 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 Bedaquiline Impurity 8.

CATO supplies Bedaquiline Impurity 8 (CAS 2122862-01-3), a pharmacopoeial impurity reference standard (molecular formula C32H32N2O2, MW 476.61 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Bedaquiline Impurity 8 (C32H32N2O2) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. 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.

CATO manufactures Bedaquiline Impurity 8 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

Molecular FormulaC32H32N2O2
Molecular Weight476.61 g/mol
AppearancePale yellow to yellow crystalline powder
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
Degree of Unsaturation (DBE)18.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1997
Nitrogen Atoms2

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