Description

Atracurium Impurity 26 Besylate is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a specified impurity of Atracurium Besylate, a neuromuscular blocking agent, and is essential for ensuring drug safety and regulatory compliance. It is primarily used by analytical chemists and quality control laboratories in the pharmaceutical industry for method development, validation, and impurity profiling studies to meet stringent ICH guidelines.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Atracurium Besylate active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: A critical component in developing and validating stability-indicating HPLC, UPLC, or LC-MS methods for potency and purity assays.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor impurity levels and ensure product consistency according to pharmacopeial standards (USP, EP).
• Stability Studies: Used to track the formation and growth of this specific impurity under various stress conditions (thermal, photolytic, hydrolytic) as part of forced degradation studies.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds, specifications, and the overall safety profile of the drug substance.
• Research & Development: Supports synthetic route optimization and process chemistry by helping to identify and control the formation of this impurity during API manufacturing.

Basic Information

Product Name	Atracurium Impurity 26 Besylate
CAS No.	1075727-02-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Atracurium Related Compound 26 Besylate; Atracurium Besylate Impurity 26; 1,2,3,4-Tetrahydro-6,7-dimethoxy-2-methyl-1-veratrylisoquinolinium benzenesulfonate (specific isomer); Laudanosine derivative besylate salt; Atracurium Degradant 26 Besylate; Noratracurium derivative besylate; (1R,2R)-2-(2-Carboxyethyl)-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methyl-1-veratrylisoquinolinium benzenesulfonate (tentative)
EINECS	Contact for details

Quality Control

Our Atracurium Impurity 26 Besylate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical characterization using techniques such as HPLC, NMR, and MS to confirm identity and purity, ensuring it meets the exacting standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided for traceability and regulatory support.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability. Keep the container tightly sealed in a cool, dry place after each use.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
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.