Description

Dezocine Impurity 5 is a specified impurity of the analgesic pharmaceutical compound Dezocine. This high-purity reference standard is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is primarily required by pharmaceutical R&D laboratories, quality assurance (QA) departments, and contract research organizations (CROs) to ensure the safety, efficacy, and regulatory compliance of Dezocine drug substances and finished products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Dezocine Impurity 5 in active pharmaceutical ingredients (APIs) and drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or GC methods to monitor impurities during stability studies.
• Quality Control & Batch Release Testing: Employed in routine QC testing to ensure drug substance and drug product batches meet stringent pharmacopeial (e.g., USP, EP) impurity limits.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., ANDA, NDA, CTA) with agencies like the FDA and EMA.
• Stability Studies: Used to track the formation and growth of this specific degradation product under various stress conditions (heat, light, humidity).
• Process Chemistry Research: Aids in optimizing synthesis and purification processes to minimize the formation of this impurity.

Basic Information

Product Name	Dezocine Impurity 5
CAS No.	50666-37-0
Molecular Formula	C16H21NO
Molecular Weight	243.35 g/mol
Synonyms	(±)-13-Amino-5,6,7,8,9,10,11,12-octahydro-5-methyl-5,11-methanobenzocyclodecen-3-ol; 13-Amino-5,6,7,8,9,10,11,12-octahydro-5-methyl-5,11-methanobenzocyclodecen-3-ol; Dezocine Related Compound; Dezocine Impurity; Wy-16225 Impurity
EINECS	Contact for details

Quality Control

Every batch of Dezocine Impurity 5 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, chromatograms, and storage recommendations.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. This compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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