Adapalene Impurity 12 CAS 1063712-23-1

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.1063712-23-1
Molecular FormulaC28H28O3
Molecular Weight412.52 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Adapalene Impurity 12 CAS 1063712-23-1 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.

As a process- or degradation-related impurity, Adapalene Impurity 12 (CAS 1063712-23-1, C28H28O3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Based on its molecular formula C28H28O3, Adapalene Impurity 12 contains a steroid core, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 412.52 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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 FormulaC28H28O3
Molecular Weight412.52 g/mol
AppearancePale yellow to yellow crystalline powder
Purity>95%
StorageStore at room temperature, 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)15.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1988

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