Description

Bupivacaine Impurity CAS NO 2125995-28-8 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 enabling precise identification and quantification of related substances. It is an essential tool for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies engaged in method development, validation, and quality control processes. The availability of this well-characterized impurity supports compliance with stringent pharmacopeial guidelines and regulatory requirements for drug substance and product development.

Application

• Pharmaceutical Quality Control (QC): Used as a certified reference material (CRM) for the identification and quantification of impurities in Bupivacaine Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods to monitor impurity profiles.
• Stability Studies: Employed to track the formation and levels of this specific impurity during forced degradation and long-term stability testing of Bupivacaine formulations.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization reports.
• Research & Development (R&D): Used in synthetic chemistry and pharmacology research to study the metabolic pathways, degradation mechanisms, and toxicological profiles associated with Bupivacaine.
• Pharmacopeial Testing: Supports testing in compliance with monographs from USP (United States Pharmacopeia), EP (European Pharmacopoeia), and other international pharmacopeias.

Basic Information

Product Name	Bupivacaine Impurity
CAS No.	2125995-28-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Bupivacaine Related Compound; Bupivacaine Process Impurity; Bupivacaine Degradant; Bupivacaine Specified Impurity; 1-Butyl-N-(2,6-dimethylphenyl)piperidine-2-carboxamide Impurity; (RS)-1-Butyl-2',6'-pipecoloxylidide Impurity; Marcaine Impurity
EINECS	Contact for details

Quality Control

Every batch of Bupivacaine Impurity (CAS 2125995-28-8) is manufactured and controlled under a strict quality management system. Our products undergo rigorous analytical testing, including advanced chromatographic techniques, to ensure high purity and accurate identification. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and impurity profile. We support compliance with ICH Q3A/B guidelines and relevant pharmacopeial standards.

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 under inert conditions or in a desiccator to maintain stability and purity. Keep away from incompatible materials.

Specification

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

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