Apremilast

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1-(3,4-Diethoxyphenyl)-2-(methyl sulfonyl)ethanamine

  • CAT NUMBER DCTI-C-3013
  • CAS NUMBER 1284768-38-2
  • MOLECULAR FORMULA C13H21NO4S
  • MOLECULAR WEIGHT 287.37

Apremilast 2-Acetamido Benzoic Acid Impurity

  • CAT Number DCTI-C-076
  • CAS Number 1809170-71-5
  • Molecular Formula C22H26N2O8S
  • Molecular Weight 478.52

Apremilast 3-Acetamido Benzoic Acid Impurity

  • CAT Number DCTI-C-075
  • CAS Number 2096492-41-8
  • Molecular Formula C22H26N2O8S
  • Molecular Weight 478.52

Apremilast Amino Sulfone Impurity

  • CAT NUMBER DCTI-C-2210
  • CAS NUMBER 253168-94-4
  • MOLECULAR FORMULA C12H19NO4S
  • MOLECULAR WEIGHT 273.35

Apremilast Des Acetyl 4-Desmethyl Impurity

  • CAT NUMBER DCTI-C-2774
  • CAS NUMBER 1384440-16-7
  • MOLECULAR FORMULA C19H20N2O6S
  • MOLECULAR WEIGHT 404.44

Apremilast Impurity RS-7

  • CAT Number DCTI-C-160
  • CAS Number 2096492-43-0
  • Molecular Formula C22H24N2O8S
  • Molecular Weight 476.5

Apremilast Impurity RS-9

  • CAT Number DCTI-C-164
  • CAS Number 2096492-44-1
  • Molecular Formula C22H24N2O8S
  • Molecular Weight 476.5

Apremilast-D3

  • CAT Number DCTI-A-047
  • CAS Number NA
  • Molecular Formula C22H21D3N2O7S
  • Molecular Weight 463.52

O-Desmethyl Apremilast

  • CAT Number DCTI-C-282
  • CAS Number 1384441-38-6
  • Molecular Formula C21H22N2O7S
  • Molecular Weight 446.47

General Information

Apremilast Impurities and Apremilast 

Daicel Pharma synthesizes high-quality Apremilast impurities, including Apremi+C39:C41 Last Impurity RS-9, Apremilast 2-Acetamido Benzoic Acid Impurity, Apremilast 3-Acetamido Benzoic Acid Impurity, Apremilast Amino Sulfone Impurity, Apremilast Des Acetyl 4-Desmethyl Impurity, Apremilast Impurity RS-7, and O-Desmethyl Apremilast. These impurities are essential for evaluating the quality, stability, and safety of Apremilast, which is an active pharmaceutical ingredient. Additionally, Daicel Pharma offers a customized synthesis of Apremilast impurities for global delivery to meet the specific needs of our customers.

Apremilast [CAS: 608141-41-9] is a medication to treat active psoriatic arthritis. It is an orally available small molecule that acts as an inhibitor of phosphodiesterase-4 (PDE-4) and an immunomodulating agent.

Apremilast: Use and Commercial Availability  

Apremilast, available under the brand name Otezla, is an FDA-approved medication for treating psoriatic arthritis, plaque psoriasis, and oral ulcers associated with Behcet disease in adults. Apremilast is the first and only FDA-approved oral medication for treating oral ulcers associated with Behcet disease.

Apremilast Structure and Mechanism of Action Apremilast Structure and Mechanism of Action

The chemical name of Apremilast is N-[2-[(1S)-1-(3-Ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide. Its chemical formula is C22H24N2O7S, and its molecular weight is approximately 460.5 g/mol.

Apremilast inhibits phosphodiesterase 4 (PDE4), causing an increase in intracellular cyclic adenosine monophosphate (cAMP) levels.

Apremilast Impurities and Synthesis

Apremilast may contain impurities formed during the manufacturing1 or storage of the drug. These impurities can be related to the starting materials, intermediates, or the final product. The impurities in a drug can affect its safety, efficacy, and quality, which is why it is necessary to identify and quantify them. Impurities in Apremilast can form due to several factors, such as degradation of the active pharmaceutical ingredient (API) or excipients, interaction with packaging materials, exposure to moisture or light, or incomplete chemical reactions during manufacturing. It is essential to synthesize and analyze the API and its impurities to ensure its quality, safety, and efficacy.

Daicel Pharma offers a Certificate of Analysis (CoA) for Apremilast impurity standards, which includes Apremi+C39:C41 Last Impurity RS-9, Apremilast 2-Acetamido Benzoic Acid Impurity, Apremilast 3-Acetamido Benzoic Acid Impurity, Apremilast Amino Sulfone Impurity, Apremilast Des Acetyl 4-Desmethyl Impurity, Apremilast Impurity RS-7, and O-Desmethyl Apremilast. The CoA is produced from a cGMP-compliant analytical facility and includes comprehensive characterization data, such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity2. Additional characterization data, such as 13C-DEPT and CHN, can also be provided on request. Daicel Pharma can create unknown Apremilast impurities or degradation products and supply labeled compounds to evaluate the effectiveness of Apremilast. Further, Daicel Pharma offers Apremilast-D3, a deuterium-labeled Apremilast standard, useful in bio-analytical research, such as BA/BE studies. Each delivery has a complete characterization report.

References
FAQ's

Frequently Asked Questions

Impurities in Apremilast are regulated by various international and national guidelines, such as the International Council for Harmonization (ICH) and the United States Pharmacopeia (USP).

Analytical testing helps detect impurities in Apremilast by providing accurate and reliable data on their presence and concentration.

Apremilast impurities are quantified by comparing the peak area or impurity height to that of the active pharmaceutical ingredient (API) in a chromatogram.

Apremilast impurities are stored at a controlled room temperature between 2-8 °C or as indicated on the Certificate of Analysis (CoA).

Note: Products protected by valid patents by a manufacturer are not offered for sale in countries having patent protection. The sale of such products constitutes a patent infringement, and its liability is at the buyer's risk.

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