Description

Bupivacaine-D9 n-Oxide is a deuterated derivative of the local anesthetic bupivacaine, specifically labeled for advanced analytical applications. This compound is a critical reference standard for ensuring accuracy and reliability in quantitative mass spectrometry and pharmacokinetic studies. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and regulatory testing facilities engaged in drug metabolism, bioanalytical method development, and impurity profiling for bupivacaine-based products.

Application

• Internal Standard for LC-MS/MS: Serves as a stable isotope-labeled internal standard for the precise quantification of bupivacaine and its metabolites in complex biological matrices like plasma, serum, and tissue homogenates.
• Pharmacokinetic & Metabolism Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion (ADME) in preclinical and clinical research.
• Bioanalytical Method Development & Validation: Used as a critical component in developing, optimizing, and validating robust HPLC and UPLC methods compliant with FDA and ICH guidelines.
• Impurity Identification and Profiling: Aids in the identification and characterization of oxidative degradation products and process-related impurities in pharmaceutical formulations.
• Forensic & Toxicological Analysis: Supports accurate quantification in forensic toxicology for cases involving bupivacaine administration.
• Doping Control Analysis: Potential use in sports anti-doping programs to detect and confirm the presence of bupivacaine.

Basic Information

Product Name	Bupivacaine-D9 n-Oxide
CAS No.	1346598-03-5
Molecular Formula	C18H19D9N2O2
Molecular Weight	305.46 g/mol (for unlabeled form; exact mass varies with isotopic distribution)
Synonyms	1-Butyl-2',6'-pipecoloxylidide-D9 N-Oxide; (RS)-1-Butyl-2',6'-pipecoloxylidide-D9 N-Oxide; (±)-Bupivacaine-d9 N-Oxide; Bupivacaine-d9 (phenyl-d9) N-Oxide; Bupivacaine (phenyl-d9) N-Oxide; Marcaine-d9 N-Oxide; Sensorcaine-d9 N-Oxide; DL-Bupivacaine-d9 N-Oxide
EINECS	Contact for details

Quality Control

Every batch of Bupivacaine-D9 n-Oxide is manufactured under strict quality control protocols to ensure the highest standards of isotopic purity and chemical identity. Our products undergo rigorous quality testing, including advanced spectroscopic and chromatographic analyses, to ensure compliance with industry standards for reference materials. Certificates of Analysis (COA) detailing isotopic enrichment, chemical purity, and analytical data (NMR, MS, HPLC) are available upon request.

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) and should be handled under anhydrous conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (Deuterium Content)	≥ 98 atom % D
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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