Omadacycline impurity 18 CAS CATO-C4X-285718

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-285718
Molecular FormulaC30H43N5O7
Molecular Weight585.69 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Omadacycline impurity 18 CAS CATO-C4X-285718 chemical structure

Description

As a process- or degradation-related impurity, Omadacycline impurity 18 (CAS CATO-C4X-285718, C30H43N5O7) 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, Omadacycline impurity 18 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 585.69 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.

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.

Physical & Chemical Properties

Molecular FormulaC30H43N5O7
Molecular Weight585.69 g/mol
AppearancePale yellow to yellow crystalline powder
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)12.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms5

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