Description

Apremilast-D8 is a high-purity, deuterium-labeled internal standard essential for precise bioanalytical quantification. This stable isotope-labeled compound is critical for ensuring accuracy and reliability in pharmacokinetic and metabolic studies, providing unmatched specificity in mass spectrometry-based assays. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical service providers engaged in advanced drug development and regulatory compliance work.

Application

• Internal Standard for LC-MS/MS quantification of Apremilast in biological matrices (plasma, serum, urine).
• Metabolite identification and profiling studies in drug metabolism and pharmacokinetics (DMPK).
• Bioanalytical method development and validation for clinical and preclinical trials.
• Quality control and assurance in pharmaceutical manufacturing of Apremilast.
• Use in stable isotope dilution assays (SIDA) for enhanced analytical precision.
• Research into the degradation pathways and stability of Apremilast.

Basic Information

Product Name	Apremilast-D8
CAS No.	1258597-45-3
Molecular Formula	C22H16D8N2O7S
Molecular Weight	464.52 g/mol (approx.)
Synonyms	N-[2-[(1S)-1-(3-Ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-1,3-dioxo-2,3-dihydro-1H-isoindol-4-yl]acetamide-d8; Apremilast (phenyl-d5, methyl-d3); CC-10004-d8; Otezla-d8; Deuterated Apremilast; Apremilast Internal Standard; Apremilast-d8 Isotope; PDE4 Inhibitor-d8.
EINECS	Contact for details

Quality Control

Our Apremilast-D8 is manufactured under strict quality systems to ensure the highest isotopic and chemical purity required for sensitive analytical applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing results from advanced characterization techniques including NMR, HPLC, and MS. We adhere to relevant industry standards for reference materials to guarantee reliable and reproducible performance in your assays.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (NMR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥98.0%
Isotopic Purity (Deuterium Content)	≥98.0 atom % D
Chemical Purity (by HPLC)	≥95.0%
Water Content (KF)	≤1.0%
Residue on Ignition	≤0.1%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.