Tretinoin Impurity 15 CAS 49816-69-5

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.49816-69-5
Molecular FormulaC13H20O
Molecular Weight192.30 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Tretinoin Impurity 15 CAS 49816-69-5 chemical structure

Description

As a process- or degradation-related impurity, Tretinoin Impurity 15 (CAS 49816-69-5, C13H20O) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

The molecular framework of Tretinoin Impurity 15 (C13H20O) is characterized by a hydroxyl group, an ether linkage, an aromatic ring system. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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 FormulaC13H20O
Molecular Weight192.30 g/mol
Purity97%+
StorageStore at 2-8°C
Solubility (reference)Soluble in chloroform, dichloromethane, ethyl acetate, DMSO
StabilityStable under recommended storage conditions
Degree of Unsaturation (DBE)4.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1971

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