Description

Bupivacaine n-Oxide Hydrochloride Salt is a high-purity pharmaceutical intermediate and reference standard. This compound is critical for analytical research, method development, and quality control processes in the synthesis of local anesthetics. It is primarily utilized by research institutions, pharmaceutical development laboratories, and quality assurance departments requiring precise chemical standards for their work. The material is supplied with comprehensive analytical documentation to ensure traceability and reliability for your critical applications.

Application

• Pharmaceutical Reference Standard: Used for the calibration of analytical instruments and validation of testing methods (HPLC, LC-MS) for bupivacaine-related compounds.
• Metabolite and Impurity Profiling: Serves as a characterized metabolite standard in pharmacokinetic and toxicological studies of the parent drug, bupivacaine.
• Process Chemistry Research: Employed in route scouting and optimization studies for the synthesis of novel local anesthetic agents or derivatives.
• Quality Control (QC) Testing: Acts as a system suitability standard and an impurity marker in the release testing of active pharmaceutical ingredients (APIs).
• Stability Studies: Used to identify and quantify degradation products in forced degradation and long-term stability programs for pharmaceutical formulations.
• Academic and Clinical Research: Supports investigative studies into the metabolism, safety profile, and structure-activity relationships of amide-type local anesthetics.

Basic Information

Product Name	Bupivacaine n-Oxide Hydrochloride Salt
CAS No.	1796927-05-3
Molecular Formula	C18H29ClN2O3 • HCl
Molecular Weight	393.35 g/mol (for the hydrochloride salt)
Synonyms	1-Butyl-N-(2,6-dimethylphenyl)-2-piperidinecarboxamide N-Oxide Hydrochloride; Bupivacaine N-Oxide HCl; Bupivacaine N-Oxide Hydrochloride; Bupivacaine N-Oxide Monohydrochloride; Bupivacaine Impurity O (Hydrochloride); Bupivacaine Related Compound O HCl; Bupivacaine Metabolite (N-Oxide) Hydrochloride Salt
EINECS	Contact for details

Quality Control

Our Bupivacaine n-Oxide Hydrochloride Salt is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure it meets the high standards required for research and pharmaceutical applications. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. We adhere to cGMP principles where applicable, and our quality systems are designed to ensure batch-to-batch consistency and traceability.

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 kept tightly sealed in a low-humidity environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 2.0%
Heavy Metals	≤ 20 ppm

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