Description

Bupivacaine Impurity (CAS NO 2125995-27-7) is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a specified impurity in the quality control and regulatory compliance of Bupivacaine, a widely used local anesthetic. It is essential for analytical laboratories and pharmaceutical manufacturers engaged in method validation, stability studies, and ensuring drug safety profiles. The availability of this well-characterized impurity is fundamental for meeting stringent pharmacopeial standards and regulatory submissions globally.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of impurities in Bupivacaine Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and GC methods in quality control laboratories.
• Stability Indicating Studies: Employed in forced degradation studies to understand the degradation pathways of Bupivacaine and to establish stability-indicating methods.
• Regulatory Compliance and Submissions: Essential for preparing drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to agencies like the FDA, EMA, and PMDA.
• Pharmacopeial Testing: Used to ensure compliance with monographs from USP (United States Pharmacopeia), EP (European Pharmacopoeia), and other international pharmacopeias.
• Research and Development: Aids in synthetic route optimization and process chemistry by helping to identify and control process-related impurities.
• Quality Assurance/Quality Control (QA/QC): Provides an in-house reference standard for routine batch release testing of Bupivacaine API.

Basic Information

Product Name	Bupivacaine Impurity
CAS No.	2125995-27-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Bupivacaine Related Compound; Bupivacaine Specified Impurity; Bupivacaine Process Impurity; 1-Butyl-N-(2,6-dimethylphenyl)piperidine-2-carboxamide Impurity; (RS)-1-Butyl-2',6'-pipecoloxylidide Impurity; Local Anesthetic Impurity; Marcaine Impurity; Sensorcaine Impurity
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 to support its use as a reference standard, including purity by HPLC, confirmation of structure, and impurity profile. A detailed Certificate of Analysis (COA) containing batch-specific results is supplied with each product, ensuring traceability and compliance with cGMP guidelines for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material should be kept in a dry environment to maintain stability. For long-term storage, consider conditions recommended for pharmaceutical reference standards.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Specification available upon request
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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