Paclitaxel Impurity N2 CAS 337515-55-6

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.337515-55-6
Molecular FormulaC22H34O3
Molecular Weight346.50 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Paclitaxel Impurity N2 CAS 337515-55-6 chemical structure

Description

Paclitaxel Impurity N2 (CAS 337515-55-6) is a certified pharmaceutical impurity reference standard with the molecular formula C22H34O3 and a molecular weight of 346.50 g/mol.

Owing to a steroid core, a hydroxyl group, an ether linkage, Paclitaxel Impurity N2 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 346.50 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

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 FormulaC22H34O3
Molecular Weight346.50 g/mol
AppearanceOff-white to pale yellow crystalline powder
Purity97%+
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)6.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2025

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