Erythromycin EP Impurity K CAS 33442-56-7

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.33442-56-7
Molecular FormulaC36H65NO12
Molecular Weight703.90 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Erythromycin EP Impurity K CAS 33442-56-7 chemical structure

Description

As a process- or degradation-related impurity, Erythromycin EP Impurity K (CAS 33442-56-7, C36H65NO12) 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, Erythromycin EP Impurity K is typically off-white to pale yellow amorphous powder. Its solid-state physicochemical attributes — including a molecular weight of 703.90 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).

Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.

As a certified reference material (CRM), Erythromycin EP Impurity K 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 FormulaC36H65NO12
Molecular Weight703.90 g/mol
Purity>90%
StorageStore at room temperature, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1966
Nitrogen Atoms1

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