Gadobutrol EP Impurity A 4HCl (Mixture of Diastereomers) CAS 2514736-59-3

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.2514736-59-3
Molecular FormulaC20H40N4O10
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Gadobutrol EP Impurity A 4HCl (Mixture of Diastereomers) CAS 2514736-59-3 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 Gadobutrol EP Impurity A 4HCl (Mixture of Diastereomers).

As a process- or degradation-related impurity, Gadobutrol EP Impurity A 4HCl (Mixture of Diastereomers) (CAS 2514736-59-3, C20H40N4O10HCl) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

The molecular framework of Gadobutrol EP Impurity A 4HCl (Mixture of Diastereomers) (C20H40N4O10HCl) is characterized by an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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.

As a certified reference material (CRM), Gadobutrol EP Impurity A 4HCl (Mixture of Diastereomers) 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 FormulaC20H40N4O10 4*HCl
Molecular Weight533.02 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
StabilityLight-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)2.0
CAS Registry Year (est.)2000
Halogen ContentCl-containing
Nitrogen Atoms4

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