Description

Dezocine Impurity 3 is a designated impurity standard of the analgesic drug Dezocine, identified by CAS NO 100667-16-1. This high-purity reference material is critical for pharmaceutical research, development, and quality control processes to ensure drug safety and efficacy. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies for method validation, impurity profiling, and compliance testing. The availability of this well-characterized impurity supports the stringent requirements of modern pharmacopoeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Dezocine and related substances.
• Impurity Profiling & Identification: Essential for identifying, monitoring, and controlling Dezocine Impurity 3 during active pharmaceutical ingredient (API) manufacturing and stability studies.
• Method Development & Validation: Serves as a critical component in developing and validating analytical methods, such as HPLC, UPLC, and LC-MS, for impurity detection.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to ensure Dezocine API and finished drug products meet specified purity limits and regulatory guidelines (e.g., ICH Q3A/B).
• Regulatory Compliance & Submissions: Supports the preparation of regulatory documentation for new drug applications (NDA), abbreviated new drug applications (ANDA), and other submissions to agencies like the FDA and EMA.
• Stability Studies: Used to track the formation of this specific impurity under various stress conditions to establish product shelf life and storage recommendations.

Basic Information

Product Name	Dezocine Impurity 3
CAS No.	100667-16-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Dezocine Related Compound 3; Dezocine Specified Impurity 3; (5R,11S,13S)-13-Amino-5,6,7,8,9,10,11,12-octahydro-5-methyl-5,11-methanobenzocyclodecen-3-ol (a Dezocine isomer); Dezocine EP Impurity C; Dezocine USP Impurity; 100667-16-1; Dezocine metabolite reference standard
EINECS	Contact for details

Quality Control

Our Dezocine Impurity 3 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure identity, purity, and consistency, aligning with pharmacopoeial expectations for reference standards. Comprehensive Certificates of Analysis (COA) are provided, detailing results from advanced chromatographic and spectroscopic methods. We support compliance with relevant ICH, USP, and EP guidelines for impurity standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. Keep the container in a dry, cool, and well-ventilated area. Handle and store in accordance with good laboratory practice.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 2.0%

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