Irinotecan EP Impurity A HCl CAS CATO-C4X-166744

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-166744
Molecular FormulaC31H34N4O6
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Irinotecan EP Impurity A HCl CAS CATO-C4X-166744 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 Irinotecan EP Impurity A HCl.

CATO supplies Irinotecan EP Impurity A HCl (CAS CATO-C4X-166744), a pharmacopoeial impurity reference standard (molecular formula C31H34N4O6HCl, MW 595.09 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Irinotecan EP Impurity A HCl (C31H34N4O6HCl) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 16.0, corresponding to approximately 16 ring(s) or double-bond equivalent(s). With a molecular weight of 595.09 g/mol, it falls into the moderately-high-molecular-weight range. 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 Irinotecan EP Impurity A HCl 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 FormulaC31H34N4O6 HCl
Molecular Weight595.09 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)16.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms4

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