Description

Bupivacaine Impurity CAS NO 2125994-25-2 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, enabling the accurate identification and quantification of related substances in Bupivacaine drug substances and finished products. It is an essential material for analytical laboratories, research institutions, and pharmaceutical manufacturers focused on method development, validation, and regulatory compliance.

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 formulations.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or GC methods for stability-indicating assays.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency and compliance with ICH guidelines.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity limits and demonstrate product safety.
• Stability Studies: Used to track the formation of degradation products in Bupivacaine under various stress conditions (e.g., heat, light, humidity).
• Research & Development: Supports metabolic studies, pharmacokinetic research, and the synthesis of novel pharmaceutical compounds related to local anesthetics.

Basic Information

Product Name	Bupivacaine Impurity
CAS No.	2125994-25-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Bupivacaine Related Compound; Bupivacaine Impurity Standard; Bupivacaine Specified Impurity; Bupivacaine Process Impurity; Local Anesthetic Impurity; (2RS)-N-(2,6-Dimethylphenyl)-1-propylpiperidine-2-carboxamide Impurity; Contact for IUPAC name and additional synonyms.
EINECS	Contact for details

Quality Control

Our Bupivacaine Impurity is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including chromatographic purity analysis and structural confirmation, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and traceability is provided with every shipment to support your quality and regulatory requirements.

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. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%

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