Azithromycin Impurity 35 CAS 117693-42-2

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.117693-42-2
Molecular FormulaC22H43NO7
Molecular Weight433.58 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Azithromycin Impurity 35 CAS 117693-42-2 chemical structure

Description

As a certified reference material (CRM), Azithromycin Impurity 35 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.

Azithromycin Impurity 35 (CAS 117693-42-2) is a certified pharmaceutical impurity reference standard with the molecular formula C22H43NO7 and a molecular weight of 433.58 g/mol.

Structurally, Azithromycin Impurity 35 (C22H43NO7) contains an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 2.0, corresponding to approximately 2 ring(s) or double-bond equivalent(s). With a molecular weight of 433.58 g/mol, it falls into the moderately-high-molecular-weight range. 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 FormulaC22H43NO7
Molecular Weight433.58 g/mol
Purity97%+
StorageStore at room temperature, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)2.0
CAS Registry Year (est.)1990
Nitrogen Atoms1

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