Description

Bupivacaine Impurity 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 serves as an essential tool for pharmaceutical manufacturers and analytical laboratories engaged in method development, validation, and impurity profiling. Precise identification and quantification of this impurity are fundamental to meeting stringent pharmacopeial standards and regulatory requirements.

Application

• Pharmaceutical Reference Standard: Primary use 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: Essential for developing and validating sensitive HPLC, UPLC, or GC methods to monitor impurity levels in compliance with ICH Q3A/B guidelines.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure Bupivacaine meets specified purity criteria and impurity limits set by pharmacopeias (USP, EP, BP).
• Stability Studies: Employed to track the formation of degradation products in Bupivacaine formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Supports synthetic chemistry research, metabolic studies, and toxicological profiling related to Bupivacaine.

Basic Information

Product Name	Bupivacaine Impurity
CAS No.	852804-30-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Bupivacaine Related Compound; Bupivacaine Impurity Standard; Bupivacaine Specified Impurity; 1-Butyl-N-(2,6-dimethylphenyl)piperidine-2-carboxamide Impurity; (RS)-1-Butyl-2',6'-pipecoloxylidide Impurity; Bupivacaine EP Impurity; Bupivacaine USP Impurity; Local Anesthetic Impurity
EINECS	Contact for details

Quality Control

Our Bupivacaine Impurity is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure high purity and accurate identification. We provide comprehensive Certificates of Analysis (COA) containing batch-specific data on identity, purity, and impurities. Our quality commitment aligns with the standards expected for pharmaceutical reference materials, supporting compliance with ICH, USP, and EP guidelines.

Storage

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

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 unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%

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