Description

Naltrexone Ep Impurity H is a high-purity chemical reference standard, specifically identified as an impurity of the pharmaceutical substance Naltrexone. This compound is critical for ensuring the quality, safety, and efficacy of Naltrexone-based drug products through rigorous analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, method development, and quality control processes. The availability of this well-characterized impurity is essential for compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Naltrexone Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or GC methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor and control impurity levels, ensuring product consistency and compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs).
• Stability Studies: Used to track the formation of degradation products in Naltrexone formulations under various stress conditions.
• Pharmacopeial Testing: Supports testing procedures as per United States Pharmacopeia (USP), European Pharmacopoeia (EP), or other international pharmacopeias.

Basic Information

Product Name	Naltrexone Ep Impurity H
CAS No.	503090-99-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Naltrexone EP Impurity H; Naltrexone Related Compound H; 17-(Cyclopropylmethyl)-4,5α-epoxy-3,14-dihydroxymorphinan-6-one Impurity H; Naltrexone Impurity H; Naltrexone Specified Impurity H; Naltrexone Process Impurity H; Naltrexone Degradant H
EINECS	Contact for details

Quality Control

Our Naltrexone Ep Impurity H is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using advanced techniques such as HPLC, GC-MS, NMR, and IR to confirm identity and purity. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data on purity, impurities, and residual solvents. Our quality standards are designed to meet the requirements for pharmaceutical reference materials, supporting compliance with cGMP, ICH guidelines, and major pharmacopeias (USP/EP).

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 product is hygroscopic (moisture-sensitive) and should be handled in a low-humidity environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual 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.