Gadobutrol Impurity 11 CAS 294-90-6

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.294-90-6
Molecular FormulaC8H20N4
Molecular Weight172.27 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Gadobutrol Impurity 11 CAS 294-90-6 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 Impurity 11.

As a process- or degradation-related impurity, Gadobutrol Impurity 11 (CAS 294-90-6, C8H20N4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Gadobutrol Impurity 11 (C8H20N4) contains an organic framework. Its physicochemical properties are representative of its class; these physicochemical properties determine the optimal preparation and storage of its standard solutions. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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 Impurity 11 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 FormulaC8H20N4
Molecular Weight172.27 g/mol
Purity97%+
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)1.0
CAS Registry Year (est.)1957
Nitrogen Atoms4

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