Description

Alvimopan (Monohydrate) is a selective, peripherally-acting mu-opioid receptor antagonist, supplied as a monohydrate crystalline solid. This compound is critical for accelerating the recovery of gastrointestinal function following bowel resection surgery, helping to manage postoperative ileus. It is primarily utilized by pharmaceutical manufacturers and research institutions engaged in the development of advanced therapeutic agents for surgical and pain management applications.

Application

• Pharmaceutical Active Ingredient (API): Primary use in the formulation of finished dosage forms for the treatment of postoperative ileus.
• Clinical Research: Serves as a key reference standard and investigational material in pharmacokinetic and pharmacodynamic studies.
• Drug Development: Used in preclinical and formulation research for new opioid-modulating therapies.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for the production of specialized drug products.
• Analytical Testing: Employed as a high-purity standard in quality control laboratories for method development and validation.

Basic Information

Product Name	Alvimopan (Monohydrate)
CAS No.	1383577-62-5
Molecular Formula	C25H32N2O4 • H2O
Molecular Weight	442.54 g/mol (Monohydrate)
Synonyms	Alvimopan Monohydrate; ADL 8-2698; LY246736; (2S)-2-[(3R,4R)-4-(3-Hydroxyphenyl)-3,4-dimethylpiperidin-1-yl]-N-(3-fluorophenyl)-N-methylpropanamide Monohydrate; LY 246736; Entereg (Brand Name, Monohydrate form); Peripherally Acting μ-Opioid Receptor Antagonist (PAM-ORA).
EINECS	Contact for details

Quality Control

Our Alvimopan (Monohydrate) is manufactured under strict quality systems suitable for pharmaceutical applications. Each batch is subjected to comprehensive analytical testing, including identity confirmation, purity assay, and impurity profiling via HPLC, to ensure it meets stringent specifications. A Certificate of Analysis (COA) detailing all test results is provided with every shipment to guarantee traceability and compliance with your quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	3.5% - 4.5%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.