Description

Oxycodone Related Compound B Cii (15 Mg) (Oxycodone n-Oxide) is a high-purity pharmaceutical reference standard, specifically designated as a related compound for the analysis of the active pharmaceutical ingredient (API) oxycodone hydrochloride. This compound is critical for ensuring the quality, safety, and regulatory compliance of oxycodone-based drug products by serving as a known impurity marker in chromatographic methods. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies engaged in research, development, and quality control of controlled substance medications.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material to identify and quantify Oxycodone n-Oxide in oxycodone API and finished dosage forms.
• Method Development and Validation: Serves as a critical component in developing and validating stability-indicating HPLC/UPLC methods for oxycodone products.
• Quality Control and Batch Release Testing: Employed in routine QC laboratories to monitor impurity levels against ICH guidelines, ensuring product safety and efficacy.
• Stability Studies: Used to track the formation of degradation products under various stress conditions (e.g., oxidative stress) as part of pharmaceutical stability programs.
• Regulatory Submissions and Compliance: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and other global health authority requirements.
• Forensic and Clinical Toxicology: Acts as a reference standard in forensic analysis and clinical studies to understand the metabolism and detectability of oxycodone and its derivatives.

Basic Information

Product Name	Oxycodone Related Compound B Cii (15 Mg) (Oxycodone n-Oxide)
CAS No.	71539-52-1
Molecular Formula	C18H21NO5
Molecular Weight	331.36 g/mol
Synonyms	Oxycodone N-Oxide; 14-Hydroxy-7,8-dihydrocodeinone N-Oxide; Oxycodone Impurity B; Oxycodone Related Substance B; 4,5α-Epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one N-Oxide; Noroxycodone N-Oxide (common misnomer); Oxycodone Degradant; Oxycodone Oxidation Impurity
EINECS	Contact for details

Quality Control

Every batch of Oxycodone Related Compound B is manufactured and analyzed under strict quality systems. Our products undergo rigorous identity, purity, and assay testing utilizing advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for all critical quality attributes.

Storage

Preserve in the original, tightly closed container, protected from light. Store at controlled room temperature, 15-30°C (59-86°F). For long-term stability, storage at 2-8°C (36-46°F) is recommended. Keep the container in a dry, well-ventilated area and handle in accordance with all applicable regulations for controlled substances.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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