Amikacin EP Impurity F CAS 197909-67-4

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.197909-67-4
Molecular FormulaC26H50N6O15
Molecular Weight686.71 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Amikacin EP Impurity F CAS 197909-67-4 chemical structure

Description

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 process- or degradation-related impurity, Amikacin EP Impurity F (CAS 197909-67-4, C26H50N6O15) 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, Amikacin EP Impurity F is typically off-white to pale yellow amorphous powder. Its solid-state physicochemical attributes — including a molecular weight of 686.71 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).

As a certified reference material (CRM), Amikacin EP Impurity F 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 FormulaC26H50N6O15
Molecular Weight686.71 g/mol
Purity>90%
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.)2013
Nitrogen Atoms6

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