Description

Naloxone Impurity 3 (Naloxone Ep Impurity C) is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development. This compound is critical for ensuring the safety and efficacy of naloxone hydrochloride, a life-saving opioid antagonist, by enabling the accurate identification and quantification of process-related impurities. It is an essential tool for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing, supporting compliance with stringent regulatory guidelines from agencies like the FDA and EMA.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Naloxone Impurity C in active pharmaceutical ingredient (API) batches.
• Method Development and Validation: Critical for developing and validating robust analytical methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control (QC) Testing: Used in routine QC laboratories to monitor and control impurity levels during naloxone API synthesis to ensure product purity meets pharmacopeial standards.
• Stability Studies: Employed in forced degradation and long-term stability studies of naloxone formulations to track impurity formation over time.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids chemists in optimizing synthesis pathways to minimize the formation of this specific impurity.

Basic Information

Product Name	Naloxone Impurity 3 (Naloxone Ep Impurity C)
CAS No.	2139253-68-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Naloxone EP Impurity C; Naloxone Related Compound C; Naloxone Impurity C; 4,5α-Epoxy-3,14-dihydroxy-17-(2-propenyl)morphinan-6-one impurity; Naloxone Process Impurity; Opioid Antagonist Impurity; Naloxone HCl Impurity
EINECS	Contact for details

Quality Control

Every batch of Naloxone Impurity 3 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A/B guidelines and relevant pharmacopeia (USP, EP) requirements for impurity standards.

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 under dry, inert conditions to maintain stability and purity. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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