Suplatast

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1-(4-aminophenoxy)-3-ethoxypropane-2-ol

  • CAT NUMBER DCTI-C-2547
  • CAS NUMBER 94056-98-1
  • MOLECULAR FORMULA C11H17NO3
  • MOLECULAR WEIGHT 211.26
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Deuterated Suplatast Tosilate

  • CAT NUMBER DCTI-A-332
  • CAS NUMBER NA
  • MOLECULAR FORMULA C16H21D5NO4S+ (without salt); C23H28D5NO7S2 (p-toluenesulfonate salt)
  • MOLECULAR WEIGHT 333.48 (without salt); 504.67 (p-toluenesulfonate salt)
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N-(4-(3-ethoxy-2-hydroxypropoxy) phenyl)-3-(methylthio)propanamide

  • CAT NUMBER DCTI-C-2548
  • CAS NUMBER 94057-02-0
  • MOLECULAR FORMULA C15H23NO4S
  • MOLECULAR WEIGHT 313.41
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N-(4-(3-ethoxy-2-hydroxypropoxy)phenyl) acrylamide

  • CAT NUMBER DCTI-C-2546
  • CAS NUMBER 145133-19-3
  • MOLECULAR FORMULA C14H19NO4
  • MOLECULAR WEIGHT 265.31
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N-(4-(3-ethoxy-2-hydroxypropoxy)phenyl)-3-hydroxypropanamide

  • CAT NUMBER DCTI-C-2549
  • CAS NUMBER NA
  • MOLECULAR FORMULA C14H21NO5
  • MOLECULAR WEIGHT 283.32
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Suplatast 2-methoxy p-toluenesulfonate Impurity

  • CAT NUMBER DCTI-C-2853
  • CAS NUMBER NA
  • MOLECULAR FORMULA C17H28NO4S+ (Free Base); C24H35S2NO7(p-toluenesulfonate salt)
  • MOLECULAR WEIGHT 342.47 (Free Base); 513.66 (p-toluenesulfonate salt)
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Suplatast Dimer Impurity 1

  • CAT NUMBER DCTI-C-2878
  • CAS NUMBER NA
  • MOLECULAR FORMULA C25H36N2O5S22+ (without salt); C39H50N2O11S4 (p-toluenesulfonate salt)
  • MOLECULAR WEIGHT 508.69 (without salt); 851.07 (p-toluenesulfonate salt)
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Suplatast Dimer Impurity 2

  • CAT NUMBER DCTI-C-2906
  • CAS NUMBER NA
  • MOLECULAR FORMULA C42H56N2O13S4 (p-toluenesulfonate salt); C28H42N2O7S22+ (without salt)
  • MOLECULAR WEIGHT 582.77(without salt); 925.15 (p-toluenesulfonate salt)
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General Information

Suplatast Impurities and Suplatast 

Daicel Pharma offers Suplatast impurities like 1-(4-aminophenoxy)-3-ethoxypropane-2-ol, N-(4-(3-ethoxy-2-hydroxypropoxy), phenyl)-3-(methylthio)propanamide, N-(4-(3-ethoxy-2-hydroxypropoxy)phenyl), acrylamide and N-(4-(3-ethoxy-2-hydroxypropoxy)phenyl)-3-hydroxypropanamide, etc. The impurities are of utmost importance when assessing the quality, stability, and biological safety of the active pharmaceutical ingredient Suplatast. Daicel Pharma specializes in synthesizing custom Suplatast impurities to meet precise customer specifications. With a commitment to worldwide delivery, Daicel Pharma ensures that customers receive the synthesized Suplatast impurities promptly and reliably.

Suplatast [CAS: 94055-75-1] is a medicine primarily used to treat allergic diseases, including asthma, atopic dermatitis, and allergic rhinitis. It is classified as an immunomodulator and suppresses the immune response associated with allergic reactions.

Suplatast: Use and Commercial Availability  

Suplatast, an innovative immunomodulator, can restore the equilibrium in the Th1/Th2 immune response and demonstrates notable clinical effectiveness in managing bronchial asthma (BA). Suplatast treats BA, allergic rhinitis, and atopic dermatitis.

Suplatast is available under Tosilart, IPD-1151T, etc., which contains the active ingredient, Suplatast.

Suplatast Structure and Mechanism of Action Suplatast Structure and Mechanism of Action

The chemical name of Suplatast is [3-[[4-(3-Ethoxy-2-hydroxypropoxy)phenyl]amino]-3-oxopropyl]dimethylsulfonium. Its chemical formula is C16H26NO4S, and its molecular weight is approximately 328.4 g/mol.

Suplatast inhibits the production of IgE, impeding cytokine production and suppressing eosinophils associated with allergies.

Suplatast Impurities and Synthesis

During the synthesis and storage of Suplatast1, impurities can arise, including related substances, degradation products, and residual solvents. It is essential to carefully monitor and control these impurities to ensure the medication’s safety, efficacy, and overall quality.

Daicel Pharma offers a comprehensive Certificate of Analysis (CoA) for impurity standards such as – 1-(4-aminophenoxy)-3-ethoxypropane-2-ol, N-(4-(3-ethoxy-2-hydroxypropoxy), phenyl)-3-(methylthio)propanamide, N-(4-(3-ethoxy-2-hydroxypropoxy)phenyl), acrylamide and N-(4-(3-ethoxy-2-hydroxypropoxy)phenyl)-3-hydroxy propenamide, etc. These impurities form in compliance with current Good Manufacturing Practices (cGMP). The CoA includes detailed characterization data, such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity, providing a thorough understanding of the impurity profile. Upon request, Daicel can also provide 13C-DEPT data for further characterization.

Furthermore, Daicel Pharma possesses the technical expertise to synthesize any unknown impurities or degradation products of Suplatast. Daicel Pharma also provides labeled compounds specifically designed to assess the effectiveness of generic versions of Suplatast. Daicel Pharma offers highly pure Deuterated Suplatast Tosilate, the deuterated-labeled standard of Suplatast for bioanalytical research and Bioavailability/Bioequivalence (BA/BE) studies.

References
FAQ's

References

Bondo Hansen, John; S0ndergard Thomsen, Mikael,. H0jgaard, Bent; Composition comprising suplatast tosilate, Conrig Pharma Aps, WO 2019/042995 Α1, March 7, 2019

Frequently Asked Questions

Analytical Methods such as Reverse Phase-High Performance Liquid Chromatography (RP-HPLC) can detect impurities in Suplatast.

Suplatast impurities can impact patient safety. Depending on their nature and concentration, contaminants can cause adverse effects or reduce the efficacy of the medication.

Acetonitrile is used to achieve optimal solubility and separation of Suplatast impurities.

Suplatast impurities are stored at a controlled room temperature between 2-8 ⁰C 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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