Description

Naltrexone Methylbromide Impurity A is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products containing naltrexone methylbromide. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, impurity profiling, and stability studies.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of this specific impurity in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation: Essential for developing, calibrating, and validating chromatographic methods, such as HPLC and UPLC, to ensure accurate detection limits.
• Quality Control & Assurance (QC/QA): Used as a system suitability standard in routine QC testing to monitor batch-to-batch consistency and purity of naltrexone methylbromide.
• Stability Studies: Employed to track the formation of this impurity over time under various stress conditions, supporting shelf-life determination and packaging decisions.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to define impurity limits and justify specifications.
• Research and Development: Supports synthetic chemistry research, including route scouting and process optimization to minimize impurity formation.

Basic Information

Product Name	Naltrexone Methylbromide Impurity A
CAS No.	1220225-86-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	17-(Cyclopropylmethyl)-4,5α-epoxy-3,14-dihydroxymorphinan-6-one Impurity A; Naltrexone Methyl Bromide Related Compound A; Naltrexone Methylbromide EP Impurity A; Naltrexone Methylbromide USP Impurity A; Naltrexone N-Methylbromide Impurity A; (5α)-17-(Cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxymorphinan-6-one Impurity A
EINECS	Contact for details

Quality Control

Our Naltrexone Methylbromide Impurity A is manufactured under strict quality systems. Each batch is subjected to comprehensive analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and consistency. We provide Certificates of Analysis (COA) with detailed results, supporting compliance with ICH Q3A/B, USP, and EP guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. Handle the material in accordance with safe laboratory practices to prevent contamination.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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