Description

Naltrexone Impurity2 CAS NO 1970226-09-5 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 involved in drug development and quality control. The material is essential for method validation, impurity profiling, and stability studies.

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: A critical component in developing and validating HPLC, UPLC, or GC methods for impurity profiling and assay determination.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency of Naltrexone products.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data for impurity identification and qualification as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Used to track the formation and growth of this specific impurity during forced degradation and long-term stability studies of Naltrexone.
• Research & Development: Serves as a key reagent in pharmaceutical R&D for studying the degradation pathways and synthesis process of Naltrexone.

Basic Information

Product Name	Naltrexone Impurity2
CAS No.	1970226-09-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Naltrexone Related Compound; Naltrexone Impurity B; Naltrexone EP Impurity; Naltrexone Process Impurity; Naltrexone Degradant; 17-(Cyclopropylmethyl)-4,5α-epoxy-3,14-dihydroxymorphinan-6-one Impurity; Noroxymorphone Impurity
EINECS	Contact for details

Quality Control

Our Naltrexone Impurity2 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 purity, identity, and impurity profiles. Our quality protocols are designed to support compliance with cGMP, ICH, and relevant pharmacopoeial 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). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
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 ≤ 1.0%
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.