Description

Naltrexone Ep Impurity C is a high-purity reference standard and pharmaceutical impurity used in analytical research and development. This compound is critical for ensuring the quality, safety, and regulatory compliance of Naltrexone, an opioid antagonist medication. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and impurity profiling. The reliable identification and quantification of this impurity are essential for meeting stringent pharmacopeial standards.

Application

• Primary use as a certified reference standard for the analytical testing of Naltrexone Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Critical component in impurity profiling and method development for HPLC, UPLC, and GC analysis in quality control laboratories.
• Essential for conducting pharmaceutical stability studies and forced degradation studies to monitor impurity formation over time.
• Used in regulatory submissions (e.g., for FDA, EMA) to establish impurity limits and validate analytical procedures.
• Supports research and development of Naltrexone-based therapies, including purity assessments of synthetic batches.
• Applied in pharmacopeial testing to verify compliance with monographs from USP, EP, or other international standards.

Basic Information

Product Name	Naltrexone Ep Impurity C
CAS No.	189016-90-8
Molecular Formula	C20H23NO4
Molecular Weight	341.41 g/mol
Synonyms	17-(Cyclopropylmethyl)-4,5α-epoxy-3,14-dihydroxymorphinan-6-one; Naltrexone EP Impurity C; Naltrexone Impurity C; Naltrexone Related Compound C; 6-Oxo-naltrexone; 6-Keto-naltrexone; Naltrexone Ketone; Naltrexone Metabolite
EINECS	Contact for details

Quality Control

Every batch of Naltrexone Ep Impurity C is manufactured and tested 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) and purity determination by advanced chromatographic techniques (HPLC, GC). Certificates of Analysis (COA) are available upon request, providing full traceability and detailed analytical results.

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. Ensure the storage area is well-ventilated and away from incompatible materials.

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)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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