General Information

Alvimopan Impurities and Alvimopan 

Daicel Pharma is a reliable source for synthesizing high-quality Alvimopan impurities, specifically Alvimopan Metabolite Formic acid salt, Alvimopan olefin impurity, etc. These impurities help assess the quality, stability, and safety of Alvimopan. Daicel Pharma also offers a custom synthesis of Alvimopan impurities, which can be shipped worldwide to meet customers’ unique requirements.

Alvimopan [CAS: 156053-89-3] is a peripherally acting μ opioid antagonist. Its primary use is to prevent postoperative ileus, or the inability of the intestines to move food and stool, after small or large bowel resection surgery. By acting on the peripheral nervous system, Alvimopan can help accelerate the recovery period of the gastrointestinal system.

Alvimopan: Use and Commercial Availability  

Alvimopan, available under the name Entereg, is a drug to speed up the time to upper and lower gastrointestinal recovery after partial large or small bowel resection surgery with primary anastomosis. Alvimopan reverses postoperative ileus after colectomy.

Alvimopan Structure and Mechanism of Action

The chemical name of Alvimopan is N-[(2S)-2-[[(3R,4R)-4-(3-Hydroxyphenyl)-3,4-dimethyl-1-piperidinyl]methyl]-1-oxo-3-phenylpropyl]glycine. Its chemical formula is C₂₅H₃₂N₂O_4, and its molecular weight is approximately 424.5 g/mol.

Alvimopan is a peripherally acting μ-opioid antagonist, binding competitively to μ-opioid receptors in the gastrointestinal tract to minimize the undesirable side effects of opioid agonists, such as constipation, without affecting analgesia or precipitating withdrawal.

Alvimopan Impurities and Synthesis

During the manufacturing of Alvimopan, impurities form from starting materials, intermediates, or reagents used in synthesis¹. They are beyond acceptable limits and can affect the drug’s quality, stability, and safety. Therefore, controlling them is necessary to ensure the drug’s quality and safety.

Daicel Pharma provides a Certificate of Analysis (CoA) for Alvimopan impurity standards, which includes Alvimopan Metabolite Formic acid salt, Alvimopan olefin impurity, etc. The CoA is from an analytical facility that adheres to current Good Manufacturing Practices (cGMP) and includes complete characterization data, such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity². We give additional characterization data such as 13C-DEPT and CHN on request. Daicel Pharma can also generate unknown Alvimopan impurities or degradation products and provide labeled compounds to assess the effectiveness of Alvimopan. Additionally, Daicel Pharma offers Alvimopan Metabolite-D5 Formic acid salt, Alvimopan-D5 Formic acid salt, and R-Alvimopan Metabolite-D5 Formic Acid salt, deuterium-labeled Alvimopan compounds used in bio-analytical research, such as BA/BE studies. A complete characterization report is part of each delivery.