BB-K 6 Disulfate Salt (Amikacin EP Impurity E Disulfate) CAS 50866-72-3(Free Base)

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.50866-72-3(Free Base)
Molecular FormulaC22H43N5O13
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

BB-K 6 Disulfate Salt (Amikacin EP Impurity E Disulfate) CAS 50866-72-3(Free Base) chemical structure

Description

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

As a process- or degradation-related impurity, BB-K 6 Disulfate Salt (Amikacin EP Impurity E Disulfate) (CAS 50866-72-3(Free Base), C22H43N5O13H2O4S) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

The molecular framework of BB-K 6 Disulfate Salt (Amikacin EP Impurity E Disulfate) (C22H43N5O13H2O4S) is characterized by an amide group, a sulfone group, a carboxylic acid group, a hydroxyl group, an ether linkage. 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. 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.

Physical & Chemical Properties

Molecular FormulaC22H43N5O13 2*H2O4S
Molecular Weight683.68 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)3.0
UV AbsorptionUV-absorbing
Nitrogen Atoms5
Sulfur Atoms1

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