Description

Atracurium Impurity C (Mixture Of Diastereomers) is a critical pharmaceutical reference standard used for analytical and research purposes. This compound is essential for ensuring the quality, safety, and efficacy of the neuromuscular blocking agent atracurium besylate. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and regulatory bodies for method development, validation, and impurity profiling. The availability of a well-characterized impurity standard is fundamental for compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Impurity Profiling and Control: Used as a certified reference material for the identification and quantification of impurities in atracurium besylate active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Serves as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for stability-indicating assays.
• Quality Control and Assurance (QC/QA): Employed in routine batch release testing to monitor impurity levels and ensure product consistency against ICH Q3A/B guidelines.
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough understanding and control of the drug substance impurity profile.
• Stability Studies: Used as a marker to track degradation pathways and establish shelf-life for atracurium-based formulations.
• Research and Development: Facilitates studies on the degradation chemistry, metabolism, and pharmacokinetics of atracurium besylate.

Basic Information

Product Name	Atracurium Impurity C (Mixture Of Diastereomers)
CAS No.	86293-35-8
Molecular Formula	C53H72N2O12
Molecular Weight	929.15 g/mol
Synonyms	Atracurium Related Compound C; Atracurium Besylate Impurity C; 1,2,3,4-Tetrahydro-6,7-dimethoxy-2-methyl-1-veratrylisoquinolinium, 2-[3-[(1,2,3,4-tetrahydro-6,7-dimethoxy-2-methyl-1-isoquinolinyl)carbonyloxy]propoxy]-4-[(1,2,3,4-tetrahydro-6,7-dimethoxy-2-methyl-1-isoquinolinyl)carbonyloxy]butanedioate (1:?); Laudanosine Isoquinolinium Derivative; Bis-tetrahydroisoquinolinium Derivative; Atracurium Degradant C
EINECS	Contact for details

Quality Control

Every batch of Atracurium Impurity C is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assessment, and impurity profiling using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure it meets the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing batch-specific results and confirming compliance with relevant pharmacopeial expectations.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccation.

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% (sum of diastereomers)
Individual Diastereomer Ratio	Specified on COA
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
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.