Description

Atracurium Besylate Impurity CAS NO 1075726-99-6 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of Atracurium Besylate, a non-depolarizing neuromuscular blocking agent. This impurity is critical for method validation, stability studies, and ensuring the safety and efficacy of the final drug product by accurately identifying and quantifying related substances. It is an essential material for analytical laboratories, regulatory affairs, and R&D departments within the pharmaceutical and biotechnology sectors focused on neuromuscular drug development.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of specific impurities in Atracurium Besylate active pharmaceutical ingredient (API) and finished formulations.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling in compliance with ICH Q2(R1) and Q3B(R2) guidelines.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies to monitor the formation of this impurity and establish shelf-life specifications.
• Quality Control & Batch Release Testing: A critical component in the routine QC testing of Atracurium Besylate batches to ensure impurity levels remain within specified safety thresholds.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Research on Degradation Pathways: Used in research to understand the chemical degradation mechanisms of Atracurium Besylate under various stress conditions.

Basic Information

Product Name	Atracurium Besylate Impurity
CAS No.	1075726-99-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Atracurium Besylate Related Compound; Atracurium Impurity; Atracurium Besylate Degradant; 2-(2-Carboxyethyl)-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methylisoquinolinium Benzenesulfonate; Laudanosine Derivative; Isoquinolinium, 1,2,3,4-tetrahydro-6,7-dimethoxy-2-methyl-2-(3-oxo-3-ethoxypropyl)-, benzenesulfonate; Atracurium Besylate Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Atracurium Besylate Impurity (CAS 1075726-99-6) is manufactured and analyzed under strict quality systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and consistency in line with current industry standards for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, impurities, and identification.

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. For long-term storage, consider storing under inert atmosphere to preserve stability.

Specification

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