Description

Atracurium Ep Impurity D is a high-purity reference standard and pharmaceutical impurity critical for analytical research and quality control. This compound is essential for the accurate identification, quantification, and monitoring of process-related impurities in the synthesis of the neuromuscular blocking agent Atracurium Besylate. It is primarily used by pharmaceutical R&D laboratories, quality assurance departments, and contract research organizations (CROs) to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for calibrating analytical instruments and validating testing methods.
• Impurity Profiling & Control: Used in HPLC, LC-MS, and GC-MS analysis to identify and quantify this specific impurity in Atracurium Besylate active pharmaceutical ingredient (API) and finished drug products.
• Method Development & Validation: A critical component in developing and validating stability-indicating assay methods for Atracurium and related substances.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing data on impurity levels to meet ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed in forced degradation and long-term stability studies to track impurity formation over time and under various stress conditions.
• Process Chemistry Research: Used by synthetic chemists to understand and optimize the Atracurium manufacturing process to minimize impurity formation.

Basic Information

Product Name	Atracurium Ep Impurity D
CAS No.	1075726-91-8
Molecular Formula	C53H72N2O122+ • 2X-
Molecular Weight	Contact for details
Synonyms	Atracurium Impurity D; Atracurium Related Compound D; 1,2,3,4-Tetrahydro-6,7-dimethoxy-2-methyl-1-veratrylisoquinolinium, compound with pentamethylene 1,5-bis[1-(3,4-dimethoxyphenyl)-2-methyl-3,4,5,6-tetrahydro-2H-2-benzazepinium-1-yl] carboxylate (2:1); Atracurium EP Impurity D; Atracurium Besylate Impurity D; Atracurium USP Impurity D; (1R,2R)-1-(3,4-Dimethoxyphenyl)-2-methyl-1,2,3,4-tetrahydro-6,7-dimethoxyisoquinolin-2-ium
EINECS	Contact for details

Quality Control

Every batch of Atracurium Ep Impurity D is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic and spectroscopic techniques to ensure compliance with pharmacopeial standards (EP, USP) and customer-specific requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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