Polymyxin Impurity 31 CAS CATO-C4X-225531

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-225531
Molecular FormulaC56H96N16O13
Molecular Weight1201.46 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Polymyxin Impurity 31 CAS CATO-C4X-225531 chemical structure

Description

As a process- or degradation-related impurity, Polymyxin Impurity 31 (CAS CATO-C4X-225531, C56H96N16O13) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, Polymyxin Impurity 31 is typically pale yellow to yellow amorphous powder. Its solid-state physicochemical attributes — including a molecular weight of 1201.46 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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), Polymyxin Impurity 31 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 FormulaC56H96N16O13
Molecular Weight1201.46 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
Degree of Unsaturation (DBE)17.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms16

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