Description

Naloxone Ep Impurity F CAS NO 2139253-69-1 is a high-purity chemical reference standard, specifically identified as a process-related impurity of Naloxone. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing, ensuring the safety and efficacy of the final drug product. It is primarily required by pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and contract research organizations (CROs) involved in the production and testing of Naloxone and related opioid antagonist formulations.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Naloxone Ep Impurity F in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and GC methods to establish specificity, accuracy, and detection limits for impurity profiling.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines and pharmacopeial standards (USP, EP).
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress conditions (e.g., heat, humidity, light) during drug shelf-life studies.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate thorough impurity control.
• Research & Development: Used in synthetic chemistry research to understand and optimize the Naloxone manufacturing process to minimize impurity formation.

Basic Information

Item	Details
Product Name	Naloxone Ep Impurity F
CAS No.	2139253-69-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Naloxone EP Impurity F; Naloxone Impurity F; Naloxone Related Compound F; Naloxone Process Impurity F; 17-Allyl-4,5α-epoxy-3,14-dihydroxymorphinan-6-one Impurity; Opioid Antagonist Impurity; Naloxone Specified Impurity
EINECS	Contact for details

Quality Control

Our Naloxone Ep Impurity F is manufactured 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 batch-specific results for identity, purity, and impurities. Our quality commitment aligns with the principles of current Good Manufacturing Practice (cGMP) and relevant ICH guidelines.

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. Handle the container with care to prevent breakage and moisture ingress.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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