Description

Bupivacaine Impurity is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the widely used local anesthetic, Bupivacaine, by serving as a benchmark in impurity profiling and method validation. It is an essential material for pharmaceutical R&D laboratories, quality control units, and regulatory bodies focused on compliance and drug substance characterization.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Bupivacaine Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating chromatographic methods (HPLC, UPLC, GC) to ensure accurate impurity detection.
• Quality Control & Assurance: Employed in routine QC testing to monitor impurity levels against established pharmacopeial limits (e.g., ICH Q3A/B guidelines) for batch release.
• Stability Studies: Used to track the formation of degradation products in Bupivacaine formulations under various stress conditions (heat, light, humidity).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Facilitates studies on the synthesis pathways, degradation mechanisms, and metabolic pathways of Bupivacaine.

Basic Information

Product Name	Bupivacaine Impurity
CAS No.	852669-91-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Bupivacaine Related Compound; Bupivacaine Process Impurity; 1-Butyl-N-(2,6-dimethylphenyl)piperidine-2-carboxamide impurity; (2,6-Dimethylphenyl)[1-(2-methylpropyl)piperidin-2-yl]methanone; Bupivacaine Degradant; Bupivacaine Specified Impurity; Local Anesthetic Impurity
EINECS	Contact for details

Quality Control

Every batch of our Bupivacaine Impurity (CAS 852669-91-1) is manufactured and tested under strict quality systems. We provide comprehensive analytical data to support its use as a reference standard, including characterization by advanced spectroscopic and chromatographic techniques. A detailed Certificate of Analysis (COA) is supplied with each shipment, confirming identity, purity, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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