Tobramycin Impurity 21 CAS CATO-C4X-220021

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-220021
Molecular FormulaC30H49N7O14
Molecular Weight731.75 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Tobramycin Impurity 21 CAS CATO-C4X-220021 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 Tobramycin Impurity 21.

Tobramycin Impurity 21 (CAS CATO-C4X-220021) is a certified pharmaceutical impurity reference standard with the molecular formula C30H49N7O14 and a molecular weight of 731.75 g/mol.

Tobramycin Impurity 21 (C30H49N7O14) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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), Tobramycin Impurity 21 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 FormulaC30H49N7O14
Molecular Weight731.75 g/mol
Purity97%+
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)10.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms7

Related Tobramycin Standards

Recommended Standards

Why CATO?