Description

Atracurium Impurity 16 is a specified impurity associated with the neuromuscular blocking agent Atracurium Besylate. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development and validation. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and regulatory affairs professionals to ensure drug purity, safety, and compliance with stringent pharmacopeial guidelines such as USP and ICH.

Application

• Pharmaceutical 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: Essential for developing and validating stability-indicating HPLC/UPLC methods in accordance with ICH Q2(R1) guidelines.
• Quality Control & Assurance: Employed in routine QC testing to monitor impurity profiles and ensure batch-to-batch consistency of Atracurium-based pharmaceuticals.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs) and new drug applications (NDAs).
• Stability Studies: Used to track the formation of degradation products under various stress conditions as part of forced degradation and long-term stability testing programs.
• Research & Development: Facilitates process chemistry research aimed at understanding and minimizing impurity formation during the synthesis of Atracurium Besylate.

Basic Information

Product Name	Atracurium Impurity 16
CAS No.	2024603-91-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Atracurium Related Compound 16; Atracurium Besylate Impurity 16; Laudanosine Impurity; 1,2,3,4-Tetrahydro-6,7-dimethoxy-2-methyl-1-veratrylisoquinoline; (R)-Laudanosine; Tetrahydroapaverine derivative
EINECS	Contact for details

Quality Control

Every batch of Atracurium Impurity 16 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC/UPLC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. For long-term storage, consider storing desiccated at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (NMR)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual 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.