Efinaconazole Impurity 34 CAS 135270-08-5

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.135270-08-5
Molecular FormulaC12H21NO4
Molecular Weight243.30 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Efinaconazole Impurity 34 CAS 135270-08-5 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.

Efinaconazole Impurity 34 (CAS 135270-08-5) is a certified pharmaceutical impurity reference standard with the molecular formula C12H21NO4 and a molecular weight of 243.30 g/mol.

Based on its molecular formula C12H21NO4, Efinaconazole Impurity 34 contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 243.30 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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 FormulaC12H21NO4
Molecular Weight243.30 g/mol
AppearanceWhite to pale yellow crystalline powder
Purity>95%
StorageStore at 2-8°C, 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; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)3.0
UV AbsorptionUV-absorbing
CAS Registry Year (est.)1995
Nitrogen Atoms1

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