Description

Bupivacaine Impurity A CAS NO 205993-83-5 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the widely used local anesthetic, Bupivacaine. It is an essential tool for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies engaged in method development, validation, and impurity profiling. The availability of this well-characterized impurity standard is fundamental for maintaining the highest standards in pharmaceutical production and quality control.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify and quantify this specific impurity in Bupivacaine Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to ensure accurate detection and measurement.
• Quality Control and Release Testing: Employed in routine QC laboratories to monitor batch-to-batch consistency and ensure impurity levels are within pharmacopeial limits (e.g., USP, EP, ICH guidelines).
• Stability Studies: Used to track the formation of this impurity over time under various stress conditions, supporting shelf-life determination and packaging decisions.
• Regulatory Submissions and Compliance: Essential for preparing documentation for regulatory agencies (FDA, EMA, etc.) to demonstrate thorough impurity characterization and control strategies.
• Research and Development: Utilized in R&D to study the degradation pathways of Bupivacaine and to synthesize purer API batches by understanding and minimizing impurity formation.

Basic Information

Product Name	Bupivacaine Impurity A
CAS No.	205993-83-5
Molecular Formula	C18H28N2O
Molecular Weight	288.43 g/mol
Synonyms	1-Butyl-2',6'-pipecoloxylidide Impurity A; Bupivacaine Related Compound A; (RS)-1-Butyl-N-(2,6-dimethylphenyl)piperidine-2-carboxamide Impurity A; Desbutyl Bupivacaine; Bupivacaine EP Impurity A; Bupivacaine USP Impurity A; Bupivacaine Degradant; 2',6'-Pipecoloxylidide, 1-butyl-, impurity A
EINECS	Contact for details

Quality Control

Our Bupivacaine Impurity A is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural elucidation via techniques like NMR and Mass Spectrometry, to ensure it meets the exacting standards required for pharmaceutical reference materials. Certificates of Analysis (COA) are provided, detailing batch-specific results and confirming compliance with relevant pharmacopeial monographs (USP, EP) and ICH Q3A/B guidelines.

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 COA. The product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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