Lidocaine Base API Manufacturer in India

Swapnroop Pharma · WHO-GMP Certified · +91 87670 62101

Lidocaine Base API

Lidocaine Base is a synthetic amide-type local anesthetic that produces reversible blockade of nerve conduction. It is also known as lignocaine and is widely used in pharmaceutical formulations requiring local or regional anesthesia. Lidocaine is also classified pharmacologically as a class IB antiarrhythmic agent.

Lidocaine Base acts primarily by blocking voltage-gated sodium channels in neuronal membranes. This reduces sodium-ion influx and prevents the initiation and propagation of action potentials, resulting in reversible local loss of sensation.

Lidocaine Base API Manufacturer in India

Lidocaine Base is an established local anesthetic pharmaceutical API manufactured through controlled chemical synthesis, purification and crystallization.

Important API quality attributes include identity, assay, related substances, water content, residue on ignition, residual solvents and elemental impurities.

Chemical Information

CAS Number: 137-58-6
Molecular Formula: C14H22N2O
Molecular Weight: 234.34 g/mol
IUPAC Name: 2-(Diethylamino)-N-(2,6-dimethylphenyl)acetamide
Synonyms: Lidocaine, Lignocaine, Xylocaine
Drug Class: Local Anesthetic
Pharmacological Class: Amide Local Anesthetic / Class IB Antiarrhythmic
Therapeutic Class: Local Anesthetic
Therapeutic Area: Anesthesiology / Pain Management / Cardiology

Mechanism of Action

Lidocaine blocks voltage-gated sodium channels in nerve-cell membranes.

By reducing sodium permeability and preventing action-potential propagation, Lidocaine produces reversible inhibition of sensory nerve conduction. At appropriate systemic concentrations, it can also act as a class IB antiarrhythmic.

Pharmaceutical Applications

Lidocaine Base is used in the development and manufacture of pharmaceutical formulations for:

  • Local anesthesia
  • Regional anesthesia
  • Topical anesthesia
  • Dental anesthesia
  • Surface anesthesia
  • Nerve-block procedures
  • Pain management
  • Antiarrhythmic therapy

Physical Characteristics

Lidocaine Base is a white to almost-white powder or crystalline solid. It has a melting point around 66–70°C and is described as practically insoluble in water.

Manufacturing Process

A controlled Lidocaine Base API manufacturing process may include:

  1. Preparation of qualified starting materials
  2. Formation of the substituted aniline intermediate
  3. Controlled amide formation
  4. Introduction of the diethylamino group
  5. Purification
  6. Crystallization
  7. Filtration
  8. Drying
  9. Milling, where required
  10. Final analytical testing
  11. GMP-compliant packaging

Quality Control Testing

Typical Lidocaine Base API testing may include:

  • Identification by IR
  • Identification by HPLC
  • Assay by HPLC
  • Related substances
  • Water content
  • Residue on ignition
  • Residual solvents
  • Elemental impurities
  • Melting point
  • Appearance
  • Stability testing

Storage

Store Lidocaine Base in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive heat, moisture and direct light. Final storage conditions should be based on validated stability data.

Pharmaceutical Research

Lidocaine Base is relevant to research involving:

  • Local anesthetics
  • Voltage-gated sodium channels
  • Nerve conduction
  • Regional anesthesia
  • Dental anesthesia
  • Topical anesthetics
  • Pain management
  • Antiarrhythmic agents
  • Class IB antiarrhythmics
  • Pharmaceutical formulation development

Lidocaine Base API Summary

Lidocaine Base is an amide-type local anesthetic API with CAS Number 137-58-6, molecular formula C14H22N2O, and molecular weight 234.34 g/mol. It works primarily by blocking voltage-gated sodium channels and is widely used in local and regional anesthetic formulations.

Detailed Specifications

Parameter Specification
Appearance White crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 99.0% – 101.0%
Loss on Drying NMT 1.0%
Residue on Ignition NMT 0.1%
Heavy Metals NMT 10 ppm
Individual Impurity NMT 0.1%
Total Impurities NMT 1.0%
Water Content NMT 1.0%
Melting Point 66°C – 70°C
Solubility Insoluble in water; soluble in methanol
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