Description

Bupivacaine Hydrochloride is a potent, long-acting local anesthetic of the amide type. It is a critical active pharmaceutical ingredient (API) valued for its extended duration of action, making it essential for prolonged surgical and post-operative pain management. This compound is primarily required by pharmaceutical manufacturers for the formulation of injectable solutions used in regional anesthesia, including epidural, spinal, and nerve blocks.

Application

• Primary Active Pharmaceutical Ingredient (API) for injectable anesthetic formulations.
• Manufacturing of solutions for epidural anesthesia during childbirth and surgical procedures.
• Production of agents for spinal anesthesia (subarachnoid block).
• Formulation of peripheral nerve blocks for targeted pain relief in limbs and specific body regions.
• Use in local infiltration anesthesia for minor surgical sites.
• Research and development of novel long-acting anesthetic and analgesic delivery systems.
• Reference standard material for analytical and quality control laboratories.

Basic Information

Product Name	Bupivacaine Hydrochloride
CAS No.	73360-54-0
Molecular Formula	C18H28N2O • HCl
Molecular Weight	324.89 g/mol
Synonyms	1-Butyl-N-(2,6-dimethylphenyl)piperidine-2-carboxamide hydrochloride; (±)-1-Butyl-2',6'-pipecoloxylidide hydrochloride; (±)-Bupivacaine hydrochloride; Bupivacaine HCl; Marcaine Hydrochloride; Sensorcaine; Vivacaine; Bupivacainium chloride
EINECS	Contact for details

Quality Control

Our Bupivacaine Hydrochloride is manufactured under strict quality management systems. It is produced to meet exacting standards suitable for pharmaceutical applications, with testing protocols aligned with major pharmacopoeial guidelines. A comprehensive Certificate of Analysis (COA) detailing identity, purity, and impurity profiles is provided with each batch to ensure traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The product is hygroscopic (moisture-sensitive) and must be kept in original packaging to minimize exposure to atmospheric humidity.

Specification

Item	Specification
Appearance	White or almost white, crystalline powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms to reference standard
Assay (HPLC)	98.5% - 101.0% (on anhydrous basis)
Water (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.0%
Specific Rotation	-0.10° to +0.10° (in methanol)

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