Description

Dezocine Impurity 4 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 the analgesic drug Dezocine. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Dezocine Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development: Serves as a critical standard for developing and validating High-Performance Liquid Chromatography (HPLC) and other chromatographic methods.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing in pharmaceutical QC laboratories to monitor impurity levels and ensure product specifications are met.
• Regulatory Compliance & Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files.
• Stability Studies: Employed in forced degradation and long-term stability studies of Dezocine to understand impurity formation pathways.
• Research & Development: Used in pharmacokinetic and metabolic studies to investigate the behavior of Dezocine-related compounds.

Basic Information

Product Name	Dezocine Impurity 4
CAS No.	76948-33-9
Molecular Formula	C16H21NO
Molecular Weight	243.35 g/mol
Synonyms	Dezocine Related Compound 4; Dezocine EP Impurity D; Dezocine USP Impurity; (1R,5R,9R)-5,9-Dimethyl-2'-hydroxy-2-(3-methylbut-2-en-1-yl)-6,7-benzomorphan; 2'-Hydroxy-5,9-dimethyl-2-(3-methyl-2-butenyl)-6,7-benzomorphan
EINECS	Contact for details

Quality Control

Every batch of Dezocine Impurity 4 is manufactured and analyzed under strict quality management systems. We provide comprehensive analytical data to support its use as a reference standard, including characterization by HPLC, MS, and NMR. A detailed Certificate of Analysis (COA) is supplied with each shipment, confirming identity, purity, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C.

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 guidelines

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