Description

Apremilast-D5 is a deuterated internal standard of the active pharmaceutical ingredient Apremilast, specifically designed for analytical applications. This high-purity compound is essential for ensuring the accuracy and reliability of quantitative analysis in pharmaceutical research and quality control. It is primarily used by analytical chemists and researchers in pharmaceutical development and contract research organizations (CROs) for precise drug quantification using mass spectrometry.

Application

• Internal Standard for LC-MS/MS and GC-MS bioanalytical method development and validation.
• Quantitative analysis of Apremilast in pharmaceutical formulations and biological matrices (e.g., plasma, serum).
• Metabolism and pharmacokinetic (PK/ADME) studies to track the parent drug.
• Stability-indicating assay methods for drug substance and product testing.
• Use in quality control laboratories for impurity profiling and assay determination.
• Calibration standard for ensuring regulatory compliance in GLP/GMP environments.

Basic Information

Product Name	Apremilast-D5
CAS No.	1258597-47-5
Molecular Formula	C22H19D5N2O7S
Molecular Weight	463.51 g/mol
Synonyms	N-[2-[(1S)-1-(3-Ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-1,3-dioxo-2,3-dihydro-1H-isoindol-4-yl]acetamide-d5; Apremilast (phenyl-d5); CC-10004-d5; Otezla-d5; Deuterated Apremilast; Apremilast Internal Standard; Apremilast-d5 (deuterated at the phenyl ring)
EINECS	Contact for details

Quality Control

Our Apremilast-D5 is manufactured under strict quality systems to ensure the highest standards of purity and isotopic enrichment required for analytical applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing purity, isotopic purity (D-content), and analytical results from techniques such as HPLC, NMR, and MS. We ensure compliance with relevant standards for reference materials.

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 kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC/MS)	Conforms
Purity (HPLC)	≥98.0%
Isotopic Purity (D-content)	≥98.0 atom % D
Chemical Purity	≥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.