Description

Bupivacaine Impurity (CAS NO 2125995-25-5) is a high-purity chemical reference standard essential for pharmaceutical research and development. This compound serves as a critical impurity marker in the analytical profiling of the local anesthetic Bupivacaine, ensuring drug safety and regulatory compliance. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and contract research organizations (CROs) for method development, validation, and stability studies.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Bupivacaine Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, or GC methods to monitor impurity profiles in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release Testing: Employed in routine QC laboratories to ensure Bupivacaine batches meet stringent pharmacopeial specifications (USP, EP, BP) for impurity limits.
• Stability Studies: Used to track the formation of degradation products in Bupivacaine formulations under various stress conditions (thermal, photolytic, hydrolytic).
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs) to demonstrate control over the manufacturing process.
• Research & Development: Supports synthetic chemistry research for process optimization and impurity fate and tolerance studies during Bupivacaine synthesis.

Basic Information

Product Name	Bupivacaine Impurity
CAS No.	2125995-25-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Bupivacaine Related Compound; Bupivacaine Process Impurity; Bupivacaine Degradant; Bupivacaine Specified Impurity; Local Anesthetic Impurity; Amide-type Anesthetic Impurity; (RS)-1-Butyl-N-(2,6-dimethylphenyl)piperidine-2-carboxamide Impurity
EINECS	Contact for details

Quality Control

Our Bupivacaine Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure identity, purity, and traceability. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for all critical parameters. Our quality standards align with the requirements for pharmaceutical reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent absorption of atmospheric moisture. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified 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.