Irinotecan EP Impurity L Hydrochloride Trihydrate CAS 3105679-83-9

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.3105679-83-9
Molecular FormulaC33H38N4O6
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Irinotecan EP Impurity L Hydrochloride Trihydrate CAS 3105679-83-9 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 L Hydrochloride Trihydrate.

As a process- or degradation-related impurity, Irinotecan EP Impurity L Hydrochloride Trihydrate (CAS 3105679-83-9, C33H38N4O6HClH2O) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Irinotecan EP Impurity L Hydrochloride Trihydrate (C33H38N4O6HClH2O) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. It is notably hygroscopic, halogen substitution raises its density and boiling point, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

As a certified reference material (CRM), Irinotecan EP Impurity L Hydrochloride Trihydrate 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 FormulaC33H38N4O6 HCl 3*H2O
Molecular Weight641.16 g/mol
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)15.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2005
Halogen ContentCl-containing
Nitrogen Atoms4

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