Mepivacaine API Manufacturer in India

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Mepivacaine API

Mepivacaine is an amide-type local anesthetic used to produce temporary loss of sensation in a localized area. It works by blocking voltage-gated sodium channels in nerve cells, thereby inhibiting the initiation and transmission of nerve impulses.

Mepivacaine is primarily used in local and regional anesthesia, including dental anesthesia and selected surgical or diagnostic procedures.

Mepivacaine API Manufacturer in India

Mepivacaine is a specialized local anesthetic pharmaceutical API used in the development and manufacture of injectable and dental anesthetic formulations.

Key quality attributes include identity, assay, related substances, water content, residual solvents, elemental impurities and stereochemical purity, according to the applicable API specification.

Chemical Information

CAS Number: 96-88-8
Molecular Formula: C15H22N2O
Molecular Weight: 246.35 g/mol
Chemical Name: Mepivacaine
Drug Class: Amide Local Anesthetic
Therapeutic Class: Local Anesthetic
Therapeutic Area: Anesthesiology / Dentistry
Molecule Type: Synthetic Small Molecule

Mechanism of Action

Mepivacaine produces local anesthesia primarily by reversibly blocking voltage-gated sodium channels in neuronal membranes.

This reduces sodium ion influx and prevents the generation and propagation of action potentials along peripheral nerves.

Its mechanism includes:

  • Reversible sodium-channel blockade
  • Inhibition of action-potential generation
  • Reduction of nerve impulse conduction
  • Temporary loss of localized sensation

Pharmaceutical Applications

Mepivacaine API is used in pharmaceutical development for:

  • Local anesthesia
  • Regional anesthesia
  • Dental anesthesia
  • Peripheral nerve blocks
  • Infiltration anesthesia
  • Surgical and diagnostic procedures requiring localized anesthesia

Dosage Form Applications

Mepivacaine is commonly used in:

  • Injectable solutions
  • Dental anesthetic preparations
  • Local anesthetic formulations
  • Regional anesthesia preparations

Mepivacaine hydrochloride is the commonly used pharmaceutical salt form.

Physical Characteristics

Mepivacaine is a solid pharmaceutical compound, while its hydrochloride salt is commonly supplied for pharmaceutical formulation. Appearance and solid-state characteristics should be controlled according to the applicable API specification.

Manufacturing Process

A controlled Mepivacaine API manufacturing process may involve:

  1. Selection of qualified starting materials
  2. Preparation of substituted piperidine intermediates
  3. Controlled chemical synthesis
  4. Amide formation
  5. Purification
  6. Salt formation, where applicable
  7. Crystallization
  8. Filtration
  9. Controlled drying
  10. Final analytical testing
  11. Pharmaceutical-grade packaging

Quality Control Testing

Typical Mepivacaine API testing may include:

  • Identification by IR
  • HPLC identification
  • Assay by HPLC
  • Related substances
  • Water content
  • Residual solvents
  • Elemental impurities
  • Optical purity / stereochemical purity
  • Residue on ignition
  • Microbial quality where applicable
  • Stability testing

Storage

Store Mepivacaine API in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive moisture, heat and direct light.

Pharmaceutical Research

Mepivacaine is relevant to research involving:

  • Local anesthetic pharmacology
  • Voltage-gated sodium channels
  • Nerve conduction
  • Regional anesthesia
  • Dental anesthesia
  • Peripheral nerve blocks
  • Injectable anesthetic formulations
  • Pain-management research

Mepivacaine API Summary

Mepivacaine is an amide-type local anesthetic with CAS Number 96-88-8, molecular formula C15H22N2O, and molecular weight 246.35 g/mol. It is primarily associated with local and regional anesthesia, including dental procedures and peripheral nerve blocks.

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%
Heavy Metals NMT 10 ppm
pH (1% Solution) 5.0 – 7.0
Individual Impurity NMT 0.5%
Total Impurities NMT 2.0%
Water Content NMT 1.0%
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