Mivacurium Chloride API Manufacturer in India

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Mivacurium Chloride API

Mivacurium Chloride is a pharmaceutical active ingredient belonging to the class of short-acting, nondepolarizing neuromuscular blocking agents. It acts by competitively antagonizing acetylcholine at cholinergic receptors on the motor end plate, producing temporary blockade of neuromuscular transmission. FDA labeling describes Mivacron injection as a short-acting, nondepolarizing skeletal muscle relaxant intended for intravenous administration.

Mivacurium Chloride has the molecular formula C₅₈H₈₀Cl₂N₂O₁₄ and molecular weight 1100.18 g/mol. Its CAS Number is 106861-44-3.

About Mivacurium Chloride API

Mivacurium is a bisbenzylisoquinolinium-based neuromuscular blocker. It produces neuromuscular blockade by competing with acetylcholine at nicotinic receptors located at the neuromuscular junction. Its relatively short duration of action distinguishes it from several longer-acting nondepolarizing neuromuscular blocking agents.

Mivacurium Chloride consists of three stereoisomeric components. According to FDA labeling, the trans-trans and cis-trans stereoisomers together comprise approximately 92%–96% of mivacurium chloride.

Key Features of Mivacurium Chloride API

  • Active pharmaceutical ingredient
  • Nondepolarizing neuromuscular blocking agent
  • Short-acting skeletal muscle relaxant
  • Bisbenzylisoquinolinium derivative
  • CAS Number: 106861-44-3
  • Molecular formula: C₅₈H₈₀Cl₂N₂O₁₄
  • Molecular weight: 1100.18 g/mol
  • Consists of three stereoisomeric components
  • Water-soluble pharmaceutical compound
  • Used in pharmaceutical applications involving neuromuscular blockade
  • Suitable for pharmaceutical research, development and manufacturing subject to applicable quality and regulatory requirements. 

Pharmaceutical Applications

Mivacurium Chloride is used as a short-acting, nondepolarizing skeletal muscle relaxant. It is administered intravenously in clinical settings requiring temporary neuromuscular blockade, including use as an adjunct to general anesthesia and to facilitate tracheal intubation.

Because mivacurium produces temporary skeletal-muscle paralysis, its clinical administration requires appropriately trained healthcare professionals and suitable monitoring.

Mechanism of Action

Mivacurium produces neuromuscular blockade by competitively antagonizing acetylcholine at nicotinic cholinergic receptors located at the motor end plate.

By preventing acetylcholine from activating these receptors, mivacurium inhibits neuromuscular transmission and produces skeletal-muscle relaxation.

Chemical and Physical Characteristics

Mivacurium Chloride is a highly complex bisbenzylisoquinolinium compound. The pharmaceutical substance contains three stereoisomeric components, with the trans-trans and cis-trans forms representing the major components.

The molecular formula is C₅₈H₈₀Cl₂N₂O₁₄, and the molecular weight is approximately 1100.18 g/mol.

Mivacurium chloride is reported to be soluble in water. The marketed injectable formulation contains mivacurium chloride equivalent to 2 mg/mL mivacurium in Water for Injection and has a formulation pH of 3.5–5.0.

Quality and Analytical Considerations

Mivacurium Chloride API requires appropriate analytical characterization because of its complex molecular structure and stereoisomeric composition.

Quality-control testing may include identity, assay, related substances, stereoisomeric composition, water content, residual solvents, inorganic impurities and other applicable quality attributes.

Analytical methods and acceptance criteria should be based on the applicable validated API specification and regulatory requirements.

Solubility

Mivacurium Chloride is soluble in water. Commercial analytical references also report solubility in DMSO and methanol.

Environmental data report experimentally measured water solubility of approximately 1.08 × 10⁶ mg/L at pH 5 and 20°C, 1.05 × 10⁶ mg/L at pH 7 and 20°C, and 1.20 × 10⁶ mg/L at pH 9 and 20°C.

For a pharmaceutical product page, the simpler and safer CMS wording is:

Soluble in water; also soluble in DMSO and methanol.

Storage and Handling

Mivacurium Chloride API should be handled and stored according to the applicable pharmaceutical specification, stability data and safety documentation.

The material should be protected from contamination and unsuitable environmental conditions during storage and transportation.

Packaging

Mivacurium Chloride API should be supplied in suitable pharmaceutical-grade packaging designed to protect the material from contamination and environmental exposure.

Available packaging configurations and quantities should be confirmed according to customer and pharmaceutical manufacturing requirements.

Regulatory and Pharmaceutical Information

Mivacurium chloride has been used as the active ingredient in Mivacron injection, a short-acting nondepolarizing neuromuscular blocking agent. The FDA labeling specifies intravenous administration and identifies the drug substance as mivacurium chloride.

Regulatory status and commercial availability may vary between countries and should be evaluated according to applicable local requirements.

Detailed Specifications

Parameter Specification
Appearance White crystalline powder or crystals
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 0.50%
Residue on Ignition NMT 0.10%
pH (1% Solution) 3.5 – 5.5
Individual Impurity NMT 0.50%
Total Impurities NMT 0.10%
Specific Rotation −60° to −65°
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