Description

Methylnaltrexone Bromide Impurity 4 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development. This compound is critical for ensuring the safety and efficacy of Methylnaltrexone Bromide, a medication used to treat opioid-induced constipation, by accurately identifying and quantifying this specific impurity. It is an essential material for analytical chemists, quality assurance professionals, and researchers in pharmaceutical R&D and manufacturing who require reliable reference standards for method validation, stability studies, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the accurate detection and quantification of Impurity 4 in Methylnaltrexone Bromide active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity analysis.
• Quality Control and Batch Release Testing: Essential for in-house QC laboratories to establish specification limits and ensure batch-to-batch consistency and purity of the API.
• Stability Studies and Forced Degradation Studies: Employed to monitor the formation of this impurity over time under various stress conditions to determine product shelf-life.
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research and Development: Used in pharmaceutical R&D to study the synthesis pathway, degradation mechanisms, and physicochemical properties of Methylnaltrexone Bromide related substances.

Basic Information

Product Name	Methylnaltrexone Bromide Impurity 4
CAS No.	1005410-32-1
Molecular Formula	C22H28BrNO5
Molecular Weight	466.37 g/mol
Synonyms	Methylnaltrexone Bromide Related Compound 4; (R)-N-Methylnaltrexone Bromide Impurity 4; 17-(Cyclopropylmethyl)-4,5α-epoxy-3,14-dihydroxy-6-methylene-17-methylmorphinan-7-one Bromide Impurity; Methylnaltrexone Bromide EP Impurity C; Methylnaltrexone Bromide USP Impurity; Relistor Impurity 4; 6-Methylenenaltrexone Bromide Derivative
EINECS	Contact for details

Quality Control

Every batch of Methylnaltrexone Bromide Impurity 4 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques including HPLC, GC, MS, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing all test results and confirming compliance with specified purity grades. Our quality commitment aligns with cGMP principles to support your regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This product is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

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%
Assay (HPLC)	97.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm

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