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 advanced analytical chemistry.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Bupivacaine Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Serves as a critical component in developing, optimizing, and validating chromatographic methods to meet ICH Q2(R1) and other regulatory guidelines.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor impurity levels and ensure drug substance and product specifications are consistently met.
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies to understand the degradation pathways of Bupivacaine.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate comprehensive impurity control.
• Research & Development: Utilized in academic and industrial research to study the metabolism, pharmacokinetics, and synthetic pathways related to Bupivacaine.

Basic Information

Product Name	Bupivacaine Impurity
CAS No.	2125995-24-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Bupivacaine Related Compound; Bupivacaine Specified Impurity; Bupivacaine Degradant; Bupivacaine Process Impurity; (1-Butyl-2',6'-pipecoloxylidide) Impurity; Local Anesthetic Impurity; Bupivacaine Analog
EINECS	Contact for details

Quality Control

Every batch of our Bupivacaine Impurity is manufactured and analyzed under strict quality management systems. We provide comprehensive analytical data including HPLC purity, related substance profiles, and structural confirmation (NMR, MS) to ensure it meets the exacting standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) with batch-specific results is supplied with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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