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 regulatory compliance of the widely used local anesthetic, Bupivacaine Hydrochloride. It is an essential tool for pharmaceutical manufacturers and analytical laboratories engaged in method development, stability studies, and impurity profiling. The availability of this well-characterized impurity standard is fundamental for meeting stringent pharmacopeial requirements and maintaining the integrity of the drug substance throughout its lifecycle.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Bupivacaine Hydrochloride 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 (HPLC, UPLC) to ensure accurate impurity detection.
• Stability Studies: Employed to monitor the formation of degradation products in Bupivacaine formulations under various stress conditions (e.g., heat, light, humidity).
• Quality Control (QC) Testing: Acts as a system suitability standard and a calibrant in routine QC laboratories to ensure batch-to-batch consistency and compliance with specifications.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specification limits.
• Research and Development: Used in R&D to study the synthesis pathways, degradation mechanisms, and metabolic pathways related to Bupivacaine.

Basic Information

Product Name	Bupivacaine Impurity
CAS No.	780736-98-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Bupivacaine Related Compound; Bupivacaine Impurity Standard; Bupivacaine Specified Impurity; 1-Butyl-N-(2,6-dimethylphenyl)piperidine-2-carboxamide impurity; (RS)-1-Butyl-2',6'-pipecoloxylidide impurity; Bupivacaine EP Impurity; Bupivacaine USP Related Substance
EINECS	Contact for details

Quality Control

Every batch of our Bupivacaine Impurity CAS 780736-98-3 is manufactured and controlled under a strict quality management system. The product undergoes rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and stability. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results against established specifications. Our quality standards are designed to support compliance with ICH Q3A/B, USP, and EP guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The container should be kept in a dry, cool, and well-ventilated area. For long-term storage, consider storing under an inert atmosphere to prevent potential degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Report and comply with COA
Residual Solvents (GC)	Complies with ICH limits
Water Content (KF)	≤ 2.0%

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