Description

Naltrexone Methylbromide Impurity B is a high-purity reference standard and a specified impurity of Naltrexone Methylbromide, a quaternary ammonium derivative of the opioid antagonist naltrexone. This compound is critical for pharmaceutical research and development, particularly in the analytical method development and validation required for drug substance quality control. It is primarily used by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories involved in the synthesis and quality assurance of opioid antagonist APIs and related compounds.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for qualitative and quantitative analysis in HPLC, UPLC, and LC-MS methods.
• Method Development and Validation: Essential for developing, validating, and transferring analytical procedures for Naltrexone Methylbromide API according to ICH guidelines.
• Quality Control & Assurance: Used in the routine testing of active pharmaceutical ingredients (APIs) to monitor and control impurity profiles, ensuring batch-to-batch consistency and compliance with regulatory specifications.
• Stability Studies: Employed as a marker to track degradation pathways and establish shelf-life for drug products containing related compounds.
• Regulatory Submissions: Provides necessary impurity characterization data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids chemists in optimizing synthesis routes by identifying and quantifying process-related impurities.

Basic Information

Product Name	Naltrexone Methylbromide Impurity B
CAS No.	1220225-88-6
Molecular Formula	C21H26BrNO4
Molecular Weight	436.34 g/mol
Synonyms	17-(Cyclopropylmethyl)-4,5α-epoxy-3,14-dihydroxymorphinan-6-one N-Methyl Bromide Impurity B; Naltrexone Methyl Bromide Related Compound B; 6-Oxo-naltrexone methylbromide; Naltrexone N-Methylbromide Impurity B; Morphinan-6-one, 17-(cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxy-, methylbromide, impurity; (5α)-17-(Cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxymorphinan-6-one methobromide impurity B
EINECS	Contact for details

Quality Control

Every batch of Naltrexone Methylbromide Impurity B is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmaceutical reference standard requirements. Comprehensive Certificates of Analysis (COA) detailing batch-specific results are provided and available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C, in a dry environment. This material is hygroscopic (moisture-sensitive).

Specification

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

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