Description

Bupivacaine-D9 Hydrochloride is a high-purity, isotopically labeled internal standard essential for modern analytical chemistry. This deuterated compound is critical for ensuring the accuracy and reliability of quantitative mass spectrometry analyses, particularly in regulated environments. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and forensic toxicology units for method development, validation, and routine testing.

Application

• Quantitative Bioanalysis: Serves as a stable isotope-labeled internal standard for the precise LC-MS/MS quantification of bupivacaine and its metabolites in biological matrices (plasma, serum, urine).
• Pharmacokinetic/Pharmacodynamic (PK/PD) Studies: Enables accurate tracking of drug absorption, distribution, metabolism, and excretion in clinical and preclinical research.
• Forensic and Clinical Toxicology: Used in confirmatory testing for bupivacaine overdose, monitoring therapeutic drug levels, and post-mortem investigations.
• Drug Metabolism and Disposition (DMPK): Facilitates the identification and quantification of metabolite profiles during drug development.
• Method Development & Validation: A key reagent for developing robust, sensitive, and selective analytical methods compliant with FDA, EMA, and ICH guidelines.
• Quality Control in Pharmaceutical Manufacturing: Can be employed in impurity profiling and stability-indicating assay methods for bupivacaine hydrochloride drug substance and products.

Basic Information

Item	Details
Product Name	Bupivacaine-D9 Hydrochloride
CAS No.	1286973-34-9
Molecular Formula	C18H19D9N2O • HCl
Molecular Weight	328.91 g/mol (monoisotopic)
Synonyms	1-Butyl-2',6'-pipecoloxylidide-d9 hydrochloride; (±)-1-Butyl-2',6'-pipecoloxylidide-d9 hydrochloride; Bupivacaine-d9 HCl; DL-Bupivacaine-d9 hydrochloride; Bupivacaine (phenyl-d5, butyl-d4) hydrochloride; Bupivacaine-d9 (hydrochloride); Bupivacaine D9 Hydrochloride
EINECS	Contact for details

Quality Control

Every batch of Bupivacaine-D9 Hydrochloride is manufactured and analyzed under strict quality management systems. We provide comprehensive Certificates of Analysis (COA) detailing purity (by HPLC), isotopic enrichment (by MS), and identity confirmation (by NMR and IR). Our quality commitment ensures the material meets the stringent requirements for use as an internal standard in GLP and GMP-regulated studies.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This product is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Enrichment	≥ 98 atom % D
Chemical Purity (by NMR)	≥ 95%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.5%

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