Description

Atracurium Impurity B is a critical pharmaceutical reference standard used for quality control and analytical research. This compound is essential for ensuring the purity, safety, and efficacy of the neuromuscular blocking agent Atracurium Besylate. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling in compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of impurities in Atracurium Besylate active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, and other chromatographic methods for quality control laboratories.
• Pharmacopeial Compliance: Supports testing to meet the specifications of major pharmacopeias such as USP, EP, and BP for Atracurium-related substances.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies to monitor the formation of degradation products.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in academic and industrial R&D for studying the metabolism, degradation pathways, and synthesis of Atracurium and its analogs.

Basic Information

Product Name	Atracurium Impurity B
CAS No.	87046-74-0
Molecular Formula	C53H72N2O12 • 2C20H32O2
Molecular Weight	1243.5 g/mol
Synonyms	Atracurium Related Compound B; 1,2,3,4-Tetrahydro-6,7-dimethoxy-2-methyl-1-veratrylisoquinolinium, 2-(3-carboxypropionyloxy)-, dibenzenesulfonate, (1R,2R)-rel-; Laudanosine derivative of Atracurium; Atracurium Bisbenzene sulfonate Impurity B; (1R,2R)-2-(3-Carboxypropionyloxy)-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methyl-1-veratrylisoquinolinium dibenzenesulfonate
EINECS	Contact for details

Quality Control

Every batch of Atracurium Impurity B is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques like HPLC and MS to ensure compliance with pharmaceutical reference standard 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, typically between 15-25°C. The product is hygroscopic (moisture-sensitive) and should be kept in a dry environment. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
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%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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