Description

Naltrexone Impurity CAS NO 607732-61-6 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of Naltrexone, an important pharmaceutical active ingredient. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) to identify, quantify, and monitor this specific impurity in Naltrexone Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating chromatographic methods (e.g., HPLC, UPLC) to ensure accurate detection and quantification limits.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing of Naltrexone batches to verify compliance with stringent pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B guidelines).
• Stability Studies: Used to track the formation and level of this impurity during forced degradation and long-term stability studies of Naltrexone formulations.
• Regulatory Submissions: Essential for preparing regulatory documentation (e.g., CMC sections for FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Utilized in synthetic chemistry R&D to study impurity formation pathways and to develop optimized, purer synthesis routes for Naltrexone.

Basic Information

Product Name	Naltrexone Impurity
CAS No.	607732-61-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Naltrexone Related Compound; Naltrexone Impurity Standard; Naltrexone Process Impurity; 17-(Cyclopropylmethyl)-4,5α-epoxy-3,14-dihydroxymorphinan-6-one Impurity; 6-Oxonaltrexone (potential derivative); Morphinan-6-one, 17-(cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxy-, (5α)- (related); Naltrexone EP Impurity; Naltrexone USP Impurity
EINECS	Contact for details

Quality Control

Our Naltrexone Impurity is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, test methods, and results. Our quality commitment aligns with the principles of GMP and relevant ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. Keep the container in a dry, cool, and well-ventilated place. For long-term storage, consider storing under inert atmosphere if the compound is found to be easily oxidized.

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)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
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.