Ethotoin API Manufacturer & Supplier in India

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Ethotoin API Manufacturer & Supplier in India

Ethotoin is a hydantoin-class antiepileptic active pharmaceutical ingredient (API). It is chemically related to phenytoin and has anticonvulsant properties. Ethotoin has been used in pharmaceutical formulations for the management of certain seizure disorders, particularly generalized tonic-clonic and focal seizures.

What is Ethotoin?

Ethotoin is a synthetic hydantoin derivative developed as an anticonvulsant pharmaceutical ingredient. It is structurally related to phenytoin and acts primarily by reducing abnormal neuronal excitability.

CAS Number: 86-35-1
Molecular Formula: C₁₁H₁₂N₂O₂
Molecular Weight: 204.23 g/mol

Mechanism of Action

Ethotoin exerts anticonvulsant activity primarily by reducing excessive neuronal excitability. Its pharmacological activity is associated with modulation of voltage-gated sodium channels, helping stabilize neuronal membranes and reduce repetitive neuronal firing.

Its effects include:

  • Reduction of abnormal neuronal firing
  • Modulation of voltage-gated sodium channels
  • Stabilization of neuronal membranes
  • Suppression of seizure propagation

Pharmaceutical Applications

Ethotoin has been used in pharmaceutical formulations for:

  • Epilepsy
  • Focal (partial) seizures
  • Generalized tonic-clonic seizures
  • Other seizure disorders according to applicable approved labeling

The exact therapeutic application depends on the formulation and regulatory status in the relevant market.

Ethotoin API

Ethotoin is a hydantoin anticonvulsant API with defined chemical and physical characteristics. Pharmaceutical-grade material requires appropriate control of identity, assay, related substances and other quality attributes.

Typical quality evaluation may include:

  • Identification
  • Assay
  • Related substances
  • Water content
  • Residual solvents
  • Elemental impurities
  • Melting point
  • Particle-size characteristics, where applicable

Quality & Regulatory Considerations

Pharmaceutical-grade Ethotoin should comply with the applicable approved specification, pharmacopoeial requirements where applicable, and relevant regulatory standards.

A qualified supplier should provide Certificate of Analysis (CoA), specification sheet, SDS/MSDS, batch traceability and applicable regulatory documentation.

Storage

Store Ethotoin in a tightly closed container, protected from excessive moisture, heat and direct light, according to the manufacturer's approved storage and stability requirements.

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 20 ppm
pH (1% Solution) 2.0 – 4.0
Individual Impurity NMT 0.5%
Total Impurities NMT 1.0%
Water Content NMT 1.0%
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