Category
Apremilast
CAS Number
1384440-16-7
Molecular Formula
C₁₉H₂₀N₂O₆S
Molecular Weight
404.4 g/mol
Synonym

 N-Desacetyl O4-Desmethyl Apremilast ; (S)-4-Amino-2-(1-(3-ethoxy-4-hydroxyphenyl)-2-(methylsulfonyl)ethyl)isoindoline-1,3-dione ; Apremilast Impurity 12 ; 

Keywords
Impurities
Metabolites.
Pharmaceutical Standards
Fine Chemicals
Intermediates
Impurities manufacturer and Suppliers in Hyderabad india

N-Desacetyl O4-Desmethyl Apremilast (Apremilast Impurity-12) (CAS No.: 1384440-16-7, Molecular Formula: C₁₉H₂₀N₂O₆S, Molecular Weight: 404.4 g/mol) is a high-purity pharmaceutical impurity reference standard used for analytical method validation, impurity profiling, and related substance testing in drug development. It is widely applied in quality control laboratories for advanced characterization using HPLC, LC-MS, GC-MS, Mass Spectrometry, and NMR spectroscopy, enabling precise identification, quantification, and structural confirmation of Apremilast-related impurities.

This material supports regulatory-compliant workflows aligned with ICH, USP, EP, and FDA guidelines, ensuring accuracy, reproducibility, and consistency in pharmaceutical analysis, validation, and stability studies. Supplied by Manasa Life Sciences, Hyderabad, India, a trusted global manufacturer and supplier, it is accompanied by complete documentation including COA, MSDS/SDS, GMP, and GDP compliance, ensuring full traceability, regulatory acceptance, and reliable quality assurance for pharmaceutical applications.