Prucalopride

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N-Desmethoxypropyl Prucalopride

  • CAT NUMBER DCTI-C-2608
  • CAS NUMBER NA
  • MOLECULAR FORMULA C14H18ClN3O2 (Free base); C16H18ClF3N3O3 (TFA Salt)
  • MOLECULAR WEIGHT 295.77 (Free base); 392.78 (TFA Salt)

Nitroso Derivative of Prucalopride Impurity-A

  • CAT NUMBER DCTI-C-2584
  • CAS NUMBER NA
  • MOLECULAR FORMULA C14H17ClN4O3
  • MOLECULAR WEIGHT 324.77

Prucalopride Hydroxy Impurity

  • CAT NUMBER DCTI-C-2580
  • CAS NUMBER 2636673-48-6
  • MOLECULAR FORMULA C18H26ClN3O4
  • MOLECULAR WEIGHT 383.87

Prucalopride RC 4

  • CAT NUMBER DCTI-C-2579
  • CAS NUMBER 1900715-96-9
  • MOLECULAR FORMULA C18H24ClN3O3
  • MOLECULAR WEIGHT 365.86

Prucalopride Succinate Impurity 1

  • CAT NUMBER DCTI-C-2149
  • CAS NUMBER 1599434-55-5
  • MOLECULAR FORMULA C17H24ClN3O3
  • MOLECULAR WEIGHT 353.85

Prucalopride succinate Impurity-2

  • CAT NUMBER DCTI-C-2148
  • CAS NUMBER 123654-26-2
  • MOLECULAR FORMULA C9H8ClNO3
  • MOLECULAR WEIGHT 213.62

Prucalopride succinate Impurity-3

  • CAT NUMBER DCTI-C-2150
  • CAS NUMBER 2181480-01-1
  • MOLECULAR FORMULA C20H28ClN3O4
  • MOLECULAR WEIGHT 409.91

Prucalopride succinate Impurity-4

  • CAT NUMBER DCTI-C-2147
  • CAS NUMBER 1900715-98-1
  • MOLECULAR FORMULA C18H26ClN3O4
  • MOLECULAR WEIGHT 383.87

Prucalopride succinate Impurity-5

  • CAT NUMBER DCTI-C-2145
  • CAS NUMBER 129511-06-4
  • MOLECULAR FORMULA C8H8ClNO3
  • MOLECULAR WEIGHT 201.61
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General Information

Prucalopride Impurities and Prucalopride

Daicel Pharma synthesizes Prucalopride impurity standards such as Prucalopride RC 4, Prucalopride Hydroxy Impurity, Nitroso Derivative of Prucalopride Impurity-A, Prucalopride Succinate Impurity 1, Prucalopride succinate Impurity-3, Prucalopride succinate Impurity-9, Prucalopride succinate Impurity-8, N-Desmethoxypropyl Prucalopride, and more. They are crucial for the assessment of the effectiveness, stability, and safety of Prucalopride. Daicel Pharma provides a custom synthesis for Prucalopride impurities, ensuring worldwide delivery to cater to the unique requirements of our clients.

Prucalopride [CAS: 179474-81-8] is a Serotonin type-4 Receptor agonist for treating constipation. It is a dihydrobenzofurancarboxamide derivative for the symptomatic treatment of chronic constipation.

Prucalopride: Use and Commercial Availability 

Prucalopride is for adults suffering from chronic idiopathic constipation (CIC), among the most prevalent chronic functional gastrointestinal disorders globally. This drug is available under the brand name Motegrity.

Prucalopride Structure and Mechanism of Action

The chemical name of Prucalopride is 4-Amino-5-chloro-2,3-dihydro-N-[1-(3-methoxypropyl)-4-piperidinyl]-7-benzofurancarboxamide. Its chemical formula is C18H26ClN3O3, and its molecular weight is approximately 367.9 g/mol.

Prucalopride stimulates colonic peristalsis and increases bowel motility.

Prucalopride Impurities and Synthesis

Impurities in Prucalopride can arise either during manufacturing1 or degradation over time. Their presence can compromise the drug quality, effectiveness, and safety. Consequently, in-depth analysis and regulation of Prucalopride impurities are indispensable to fulfill regulatory standards and safety requirements.

Daicel Pharma offers a Certificate of Analysis (CoA) for Prucalopride impurity standards, Prucalopride RC 4, Prucalopride Hydroxy Impurity, Nitroso Derivative of Prucalopride Impurity-A, Prucalopride Succinate Impurity 1, Prucalopride succinate Impurity-3, Prucalopride succinate Impurity-9, Prucalopride succinate Impurity-8, N-Desmethoxypropyl Prucalopride, and more. The Certificate of Analysis (CoA) contains a detailed characterization report with information from techniques, including 1H NMR, 13C NMR, IR, MASS, and HPLC purity2. Additionally, upon request, we can supply supplementary data such as 13C-DEPT. Further, upon request, Daicel Pharma can offer unknown Prucalopride impurities and labeled compounds to assess the effectiveness of Prucalopride.

References
FAQ's

Frequently Asked Questions

The permissible levels of Prucalopride impurities in pharmaceutical products vary depending on regulatory guidelines and specific requirements. It is essential to comply with the established limits set by regulatory authorities to ensure the safety and quality of the drug.

Impurities in Prucalopride are regulated throughout the production process by implementing stringent quality control measures, rigorous analytical testing, and adherence to regulatory guidelines to ensure that impurity levels are within acceptable limits, thereby maintaining the safety and efficacy of the drug.

The presence of impurities in Prucalopride can impact its stability due to potential interactions or chemical reactions between the impurities and the active pharmaceutical ingredient.

Prucalopride impurities are stored preferably at a regulated room temperature of 2-8°C or as specified 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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