Description

Naltrexone Impurity 11 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the analytical characterization and quality control of Naltrexone, an opioid antagonist medication. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug purity and safety. The reliable identification and quantification of this impurity are essential for meeting stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the analysis of Naltrexone Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Method Development & Validation: Used in developing and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques.
• Quality Control & Assurance (QC/QA): Essential for impurity profiling, batch release testing, and stability studies to ensure compliance with ICH guidelines.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in studies to understand the degradation pathways and stability profile of Naltrexone.
• Pharmacopeial Testing: Employed as a system suitability standard in tests prescribed by USP, EP, or other pharmacopeias.

Basic Information

Product Name	Naltrexone Impurity 11
CAS No.	123086-68-0
Molecular Formula	C20H23NO4
Molecular Weight	341.41 g/mol
Synonyms	17-(Cyclopropylmethyl)-4,5α-epoxy-3,14-dihydroxymorphinan-6-one; 6-Oxo-naltrexone; Naltrexone EP Impurity B; Naltrexone Related Compound B; Naltrexone Impurity B; 6-Keto naltrexone; Noroxymorphone cyclopropylmethyl ketone
EINECS	Contact for details

Quality Control

Every batch of Naltrexone Impurity 11 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including identity confirmation by spectroscopic methods (IR, NMR, MS) and purity determination by chromatographic techniques (HPLC). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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