Description

Alvimopan Impurity 1 is a designated pharmaceutical reference standard used for the identification and quantification of a specific process-related impurity in the active pharmaceutical ingredient Alvimopan. This high-purity compound is critical for ensuring the quality, safety, and efficacy of the final drug product by enabling precise analytical control during development and manufacturing. It is an essential material for pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments focused on compliance and process optimization.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the qualitative and quantitative analysis of Alvimopan.
• Method Development and Validation: Critical for developing and validating robust HPLC, UPLC, or LC-MS analytical methods in QC laboratories.
• Impurity Profiling and Control: Used to establish specification limits and monitor impurity levels throughout the API synthesis and purification process.
• Regulatory Submission and Compliance: Supports regulatory filings (e.g., with FDA, EMA) by providing definitive characterization data for specified impurities.
• Stability Studies: Employed as a marker to track impurity formation and degradation pathways in stability testing of drug substances and products.
• Process Chemistry Research: Aids chemists in understanding and optimizing synthetic routes to minimize the formation of this specific impurity.

Basic Information

Product Name	Alvimopan Impurity 1
CAS No.	2250243-53-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Alvimopan Related Compound 1; Alvimopan EP Impurity 1; Alvimopan USP Impurity 1; (2S)-2-[(3R,4R)-4-(3-Hydroxyphenyl)-3,4-dimethyl-1-piperidinyl]methyl]-1,3-dihydro-3,3-dimethyl-1-[(phenylmethyl)oxy]-2H-indol-2-one; ENTEREG Impurity 1; 2250243-53-7
EINECS	Contact for details

Quality Control

Every batch of Alvimopan Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with pharmacopeial standards and customer-specific requirements. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile is provided with each shipment to support your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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