Description

Nalmefene Impurity CAS NO 91598-83-3 is a high-purity reference standard used in the analytical profiling and quality control of Nalmefene, an opioid antagonist medication. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure the safety, efficacy, and regulatory compliance of their products by accurately identifying and quantifying related substances. It is an essential material for method development, validation, and routine testing in the pharmaceutical and analytical chemistry sectors.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference standard for the identification and quantification of specific impurities in Nalmefene Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used as a critical component in developing and validating HPLC, UPLC, or GC methods to ensure accurate impurity detection.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines and pharmacopeial standards (USP, EP).
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies to understand the degradation pathways of Nalmefene.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Research & Development: Utilized in synthetic chemistry R&D for studying the metabolism, pharmacokinetics, and impurity formation mechanisms of Nalmefene.

Basic Information

Product Name	Nalmefene Impurity
CAS No.	91598-83-3
Molecular Formula	C21H25NO3
Molecular Weight	339.43 g/mol
Synonyms	17-(Cyclopropylmethyl)-4,5α-epoxy-6-methylenemorphinan-3,14-diol; 6-Methylenenaltrexone; Nalmefene Related Compound; Nalmefene Impurity Standard; 6-Methylenenaltrexol; (5α)-17-(Cyclopropylmethyl)-4,5-epoxy-6-methylenemorphinan-3,14-diol; Nalmefene Process Impurity; Opioid Antagonist Impurity
EINECS	Contact for details

Quality Control

Every batch of Nalmefene Impurity (CAS 91598-83-3) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure compliance with ICH guidelines and customer-specific requirements. 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) in a dry environment. For long-term storage, consider storing under inert atmosphere at -20°C to ensure maximum stability.

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: ≤ 0.10% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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