Description

Bupivacaine Hydrochloride is a potent, long-acting amino amide-type local anesthetic agent, widely recognized for its extended duration of action. Its primary commercial value lies in providing reliable and sustained nerve blockade for surgical and post-operative pain management. This high-purity active pharmaceutical ingredient (API) is essential for manufacturers in the pharmaceutical industry, particularly for formulating injectable solutions used in spinal, epidural, and peripheral nerve blocks.

Application

• Pharmaceutical API: Primary use as the active ingredient in injectable local anesthetic formulations.
• Surgical Anesthesia: Formulated for epidural, spinal (subarachnoid), and caudal blocks during surgical procedures.
• Post-Operative Analgesia: Used in continuous epidural infusions or nerve blocks for prolonged pain relief after surgery.
• Obstetric Analgesia: Key component in epidural solutions for labor pain management.
• Diagnostic & Therapeutic Nerve Blocks: Employed in procedures for chronic pain management, such as sympathetic blocks.
• Veterinary Medicine: Used in regional anesthesia for surgical procedures in animals.
• Research & Development: Serves as a critical reference standard and raw material in pharmacological studies and new drug development.

Basic Information

Product Name	Bupivacaine Hydrochloride
CAS No.	18010-40-7
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 HCl; Marcaine Hydrochloride; Sensorcaine; Vivacaine; Bupivacainium chloride; Bupivastesin; Carbostesin
EINECS	241-920-3

Quality Control

Our Bupivacaine Hydrochloride is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the highest standards for pharmaceutical use. Quality is verified against relevant pharmacopeial monographs (e.g., USP, EP, BP, JP). A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing specifications for identity, purity, assay, and impurity profiles to ensure supply reliability and regulatory compliance.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry, well-ventilated area. Keep the container tightly sealed to protect from moisture.

Specification

Item	Specification
Appearance	White or almost white, crystalline powder
Identification (IR)	Conforms
Identification (HPLC)	Retention time corresponds 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: ≤ 1.5%
Optical Rotation	-0.10° to +0.10° (in methanol)
pH (1% solution)	4.5 - 6.0

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