Levobupivacaine API | Local Anesthetic API Manufacturer in India

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Levobupivacaine API

Levobupivacaine is the S-enantiomer of bupivacaine and a long-acting amide-type local anesthetic. It produces reversible nerve conduction blockade by inhibiting voltage-gated sodium channels in neuronal membranes.

Levobupivacaine is used in regional and local anesthesia, including epidural, peripheral nerve block, infiltration and other regional anesthetic procedures.

Levobupivacaine API Manufacturer in India

Levobupivacaine is a specialized local anesthetic pharmaceutical API requiring controlled chemical synthesis, purification and stereochemical characterization.

Important quality attributes include identity, assay, related substances, enantiomeric purity, water content, residual solvents, elemental impurities and stability.

Chemical Information

CAS Number: 27262-48-2
Molecular Formula: C18H28N2O
Molecular Weight: 288.43 g/mol
Drug Class: Local Anesthetic
Pharmacological Class: Amide Local Anesthetic
Therapeutic Class: Local / Regional Anesthetic
Therapeutic Area: Anesthesiology / Pain Management

Mechanism of Action

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

By reducing sodium-ion influx, it prevents the generation and propagation of action potentials along peripheral nerves. This produces reversible loss of sensory and, at higher concentrations, motor nerve conduction.

Pharmaceutical Applications

Levobupivacaine is used for regional anesthesia, including:

  • Epidural anesthesia
  • Peripheral nerve blocks
  • Local infiltration
  • Regional surgical anesthesia
  • Obstetric analgesia and anesthesia
  • Postoperative pain management

Stereochemical Characteristics

Levobupivacaine is the S(-)-enantiomer of bupivacaine. Control of stereochemical purity is therefore an important aspect of API quality because the enantiomeric composition can influence pharmacological and safety characteristics.

Manufacturing Process

Typical API manufacturing may involve:

  1. Preparation of substituted aromatic intermediates
  2. Formation of the quinoline/piperidine-related intermediate system
  3. Controlled chemical transformations
  4. Introduction of the butyl substituent
  5. Stereochemical resolution or asymmetric synthesis
  6. Purification
  7. Crystallization
  8. Filtration
  9. Drying
  10. Final analytical testing
  11. Controlled packaging

Quality and Analytical Testing

Levobupivacaine API quality evaluation may include:

  • Identification by IR
  • Identification by HPLC
  • Mass spectrometry
  • Assay
  • Related substances
  • Enantiomeric purity
  • Optical rotation
  • Water content
  • Residual solvents
  • Elemental impurities
  • Residue on ignition
  • Particle-size distribution where required
  • Stability testing

Storage

Levobupivacaine should be stored in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive heat, moisture and direct light. Final storage requirements should be established through validated stability studies.

Pharmaceutical Research and Development

Levobupivacaine is relevant to research involving:

  • Local anesthetics
  • Voltage-gated sodium channels
  • Regional anesthesia
  • Epidural anesthesia
  • Peripheral nerve blocks
  • Postoperative analgesia
  • Obstetric anesthesia
  • Pain management
  • Stereoselective drug development
  • Amide-type anesthetics

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 1.0%
Residue on Ignition NMT 0.5%
Individual Impurity ≤ 0.5%
Total Impurities ≤ 1.5%
Water Content NMT 1.0%
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