Description

Meptazinol Impurity E is a designated impurity standard used in the analytical profiling and quality control of the pharmaceutical substance Meptazinol. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in chromatographic analyses. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance processes.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Meptazinol Impurity E in active pharmaceutical ingredient (API) batches.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels and ensure compliance with International Council for Harmonisation (ICH) guidelines and pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Used to track the formation of this specific degradation product during forced degradation and long-term stability studies of Meptazinol.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough impurity characterization and control strategies.
• Research and Development: Supports synthetic route optimization and impurity profiling during the drug development lifecycle.

Basic Information

Item	Details
Product Name	Meptazinol Impurity E
CAS No.	1980040-52-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Meptazinol Related Compound E; Meptazinol EP Impurity E; Meptazinol USP Impurity E; 3-Ethyl-1,2,3,4-tetrahydro-6,11-dimethyl-2,6-methano-3-benzazocin-8-ol impurity; (1R,5S,9R)-3-Ethyl-1,2,3,4,5,6-hexahydro-6,11-dimethyl-2,6-methano-3-benzazocin-8-ol impurity
EINECS	Contact for details

Quality Control

Every batch of Meptazinol Impurity E is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including identity confirmation by spectroscopic methods (e.g., IR, NMR) and purity determination by chromatographic techniques (e.g., HPLC) to ensure it meets the stringent requirements for use as a pharmaceutical reference standard. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results and confirming compliance with specified standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

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)	Meets internal specifications
Residual Solvents (GC)	Complies with ICH Q3C

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