Description

Naltrexone Methylbromide Impurity E is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound is essential for the accurate identification, quantification, and control of process-related impurities during the synthesis of Naltrexone Methylbromide, ensuring the safety and efficacy of the final Active Pharmaceutical Ingredient (API). It is primarily used by analytical chemists, quality control laboratories, and regulatory affairs professionals in the pharmaceutical and biotechnology industries to meet stringent regulatory requirements for drug substance characterization.

Application

• Pharmaceutical Impurity Profiling and Characterization: Serves as a certified reference material for the identification and quantification of specific impurities in Naltrexone Methylbromide API batches.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity detection.
• Quality Control and Batch Release Testing: Employed in routine QC testing to ensure API batches comply with established impurity limits as per ICH guidelines.
• Stability Studies: Acts as a marker to monitor the formation of degradation products under various stress conditions during drug product shelf-life studies.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough understanding and control of the manufacturing process.
• Process Chemistry Research: Aids chemists in understanding reaction pathways and optimizing synthesis to minimize the formation of this specific impurity.

Basic Information

Item	Details
Product Name	Naltrexone Methylbromide Impurity E
CAS No.	1240379-57-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Naltrexone Methyl Bromide Impurity E; Naltrexone N-oxide Impurity; 17-(Cyclopropylmethyl)-4,5α-epoxy-3,14-dihydroxymorphinan-6-one N-oxide; Noroxymorphone N-oxide derivative; Opioid antagonist impurity; Naltrexone related compound E; N-Methylnaltrexone bromide impurity E
EINECS	Contact for details

Quality Control

Every batch of Naltrexone Methylbromide Impurity E is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive testing to ensure identity, purity, and consistency, aligning with current industry best practices for reference standards. A comprehensive Certificate of Analysis (COA) detailing results from advanced analytical techniques (HPLC, NMR, MS) is provided with each shipment to support your regulatory and research needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing desiccated at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
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.