Description

Nalmefene Impurity CAS NO 738552-29-9 is a high-purity chemical reference standard used in the analytical profiling and quality control of Nalmefene, an opioid antagonist medication. This impurity is critical for pharmaceutical manufacturers and research laboratories to ensure the safety, efficacy, and regulatory compliance of their drug products. It is primarily utilized by professionals in pharmaceutical development, quality assurance, and analytical chemistry for method validation and impurity identification.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the quantitative and qualitative analysis of Nalmefene active pharmaceutical ingredient (API) and finished drug products.
• Method Development and Validation (HPLC/LC-MS): Essential for developing, optimizing, and validating chromatographic methods to accurately separate, identify, and quantify this specific impurity.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor impurity levels, ensuring they remain within International Council for Harmonisation (ICH) guidelines and pharmacopeial limits.
• Stability Studies: Employed as a marker to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings with agencies like the FDA, EMA, and other global health authorities.
• Research and Development: Supports synthetic route optimization and process chemistry studies to understand and minimize impurity formation during API manufacturing.

Basic Information

Product Name	Nalmefene Impurity
CAS No.	738552-29-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Nalmefene Related Compound; Nalmefene Process Impurity; Nalmefene Degradant; 17-Cyclopropylmethyl-4,5α-epoxy-6-methylenemorphinan-3,14-diol Impurity; Opioid Antagonist Impurity; 6-Methylenenaltrexone Impurity; (5α)-17-(Cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxy-6-methylenemorphinan Impurity
EINECS	Contact for details

Quality Control

Our Nalmefene Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and spectroscopic methods for structural verification, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. Due to its hygroscopic (moisture-sensitive) nature, the container must be kept in a dry environment. 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%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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