Irinotecan EP Impurity A HCl Trihydrate CAS 158406-44-1

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.158406-44-1
Molecular FormulaC31H34N4O6
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Irinotecan EP Impurity A HCl Trihydrate CAS 158406-44-1 chemical structure

Description

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 supplies Irinotecan EP Impurity A HCl Trihydrate (CAS 158406-44-1), a pharmacopoeial impurity reference standard (molecular formula C31H34N4O6HClH2O, MW 613.11 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C31H34N4O6HClH2O, Irinotecan EP Impurity A HCl Trihydrate contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 613.11 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

CATO manufactures Irinotecan EP Impurity A HCl Trihydrate 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 3*H2O
Molecular Weight613.11 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; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)15.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2002
Halogen ContentCl-containing
Nitrogen Atoms4

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