Gadobutrol Impurity 101 CAS 835640-27-2

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.835640-27-2
Molecular FormulaC17H30N4O8
Molecular Weight418.44 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Gadobutrol Impurity 101 CAS 835640-27-2 chemical structure

Description

CATO manufactures Gadobutrol Impurity 101 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.

Gadobutrol Impurity 101 (CAS 835640-27-2) is a certified pharmaceutical impurity reference standard with the molecular formula C17H30N4O8 and a molecular weight of 418.44 g/mol.

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, Gadobutrol Impurity 101 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 418.44 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

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.

Physical & Chemical Properties

Molecular FormulaC17H30N4O8
Molecular Weight418.44 g/mol
AppearanceOff-white to pale yellow crystalline powder
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
Degree of Unsaturation (DBE)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1986
Nitrogen Atoms4

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