Description

4-Hydroxy-n-Desbutyl Bupivacaine is a key pharmaceutical intermediate and metabolite of the local anesthetic bupivacaine. This compound matters for its critical role in analytical research, metabolism studies, and the development of high-purity active pharmaceutical ingredients (APIs). It is primarily needed by pharmaceutical R&D laboratories, analytical reference standard suppliers, and manufacturers specializing in anesthetic agents and their related metabolites.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantification and qualification of bupivacaine and its metabolites in analytical methods.
• Metabolite Research: Essential for pharmacokinetic and metabolic pathway studies of the anesthetic bupivacaine in preclinical and clinical research.
• Impurity Profiling: Serves as a specified impurity standard in the quality control of bupivacaine API, ensuring compliance with pharmacopeial limits (e.g., USP, EP).
• Analytical Method Development: Critical for developing and validating HPLC, LC-MS, and GC-MS methods for drug testing and bioanalysis.
• Chemical Synthesis Intermediate: Utilized in the synthetic pathways for novel anesthetic compounds or deuterated analogs for research.

Basic Information

Product Name	4-Hydroxy-n-Desbutyl Bupivacaine
CAS No.	51989-48-1
Molecular Formula	C13H20N2O2
Molecular Weight	236.31 g/mol
Synonyms	1-Butyl-2',6'-pipecoloxylidide, 4-Hydroxy-; 4-Hydroxy Bupivacaine Impurity; Bupivacaine Hydroxy Desbutyl Metabolite; Bupivacaine Impurity F (EP); Bupivacaine Related Compound F; Desbutyl-4-hydroxybupivacaine; 2-Piperidinecarboxamide, N-(2,6-dimethylphenyl)-1-piperidinyl-, 4-hydroxy-; PPX, 4-hydroxy-
EINECS	Contact for details

Quality Control

Our 4-Hydroxy-n-Desbutyl Bupivacaine is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical research and reference materials. Certificates of Analysis (COA) with batch-specific data are provided.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.