Description

Naltrexone Methylbromide Impurity D 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 utilized by analytical chemists and quality control laboratories 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 identifying and quantifying this specific impurity in Naltrexone Methylbromide API batches.
• Analytical Method Development and Validation: Used as a critical standard to develop, optimize, and validate HPLC, UPLC, or LC-MS methods for impurity detection.
• Quality Control and Release Testing: Employed in routine QC testing to ensure API batches comply with established impurity limits as per ICH Q3A/B guidelines.
• Stability Studies: Monitors the formation or increase of this impurity over time under various stress conditions to determine drug substance shelf-life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate control over the manufacturing process and product quality.
• Process Chemistry Research: Aids chemists in understanding and optimizing synthesis pathways to minimize the formation of this impurity.

Basic Information

Product Name	Naltrexone Methylbromide Impurity D
CAS No.	1178907-31-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	17-(Cyclopropylmethyl)-4,5α-epoxy-3,14-dihydroxymorphinan-6-one Impurity; Naltrexone Methyl Bromide Related Compound D; Naltrexone Methylbromide EP Impurity D; Naltrexone N-oxide Impurity; Morphinan-6-one, 17-(cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxy-, (5α)-; (5α)-17-(Cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxymorphinan-6-one
EINECS	Contact for details

Quality Control

Every batch of Naltrexone Methylbromide Impurity D is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic and spectroscopic techniques (HPLC, GC, NMR, MS) to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as specified on the certificate of analysis. The material should be kept in a dry environment to prevent moisture uptake.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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