Description

Bupivacaine Impurity CAS NO 2125995-26-6 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. It is an essential tool for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development and quality control. The impurity standard supports method validation, stability studies, and impurity profiling to meet stringent pharmacopeial requirements.

Application

• Pharmaceutical Impurity Profiling and Identification in Bupivacaine API and finished drug products.
• Analytical Method Development and Validation for HPLC, GC, or LC-MS assays.
• Quality Control and Stability Testing to monitor impurity levels during manufacturing and shelf-life studies.
• Regulatory Compliance and Submission, providing a certified reference material for FDA, EMA, and ICH guidelines.
• Research and Development of Bupivacaine synthesis pathways and degradation studies.
• Calibration Standard for quantitative analysis in accredited testing laboratories.

Basic Information

Product Name	Bupivacaine Impurity
CAS No.	2125995-26-6
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

Our Bupivacaine Impurity standard is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chromatographic purity and identity confirmation, to ensure it meets the exacting standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) is provided, which includes batch-specific data on purity, assay, and identification. We support compliance with ICH Q3A/B, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the product label or COA. Keep the container in a dry, cool, and well-ventilated area. Handle and store in accordance with good laboratory practices to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Complies with COA
Residual Solvents (GC)	Complies with ICH limits

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