Eszopiclone API Manufacturer & Supplier in India

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Eszopiclone API Manufacturer & Supplier in India

Eszopiclone is a non-benzodiazepine hypnotic agent belonging to the cyclopyrrolone class. It is an active pharmaceutical ingredient (API) used in pharmaceutical formulations for the treatment of insomnia, particularly for difficulties with sleep onset and sleep maintenance.

Eszopiclone acts on the GABA-A receptor complex and enhances inhibitory neurotransmission in the central nervous system, producing sedative and hypnotic effects.

What is Eszopiclone?

Eszopiclone is the S-enantiomer of zopiclone and is a structurally distinct non-benzodiazepine sedative-hypnotic compound.

CAS Number: 138729-47-2
Molecular Formula: C₁₇H₁₇ClN₆O₃
Molecular Weight: 388.81 g/mol

Mechanism of Action

Eszopiclone interacts with the GABA-A receptor complex at benzodiazepine receptor sites, enhancing the inhibitory effects of GABA in the central nervous system.

Its pharmacological activity results in:

  • Enhancement of GABAergic neurotransmission
  • Reduction of neuronal excitability
  • Sedative effects
  • Hypnotic effects
  • Promotion of sleep initiation and maintenance

Pharmaceutical Applications

Eszopiclone is used as an API in pharmaceutical formulations for:

  • Insomnia
  • Difficulty initiating sleep
  • Difficulty maintaining sleep
  • Sleep disturbances requiring pharmacological treatment

The specific indication, dosage and duration of therapy depend on the approved pharmaceutical formulation and applicable regulatory labeling.

Eszopiclone API

Eszopiclone is a chiral pharmaceutical API, and control of stereochemical identity and purity is an important quality attribute.

Typical quality evaluation may include:

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

Quality & Regulatory Considerations

Pharmaceutical-grade Eszopiclone should comply with the applicable approved specification and relevant regulatory requirements.

Because Eszopiclone is a chiral API, appropriate control of the undesired enantiomer is particularly important for pharmaceutical quality.

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

Storage

Store Eszopiclone 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%
Heavy Metals NMT 10 ppm
pH (1% Solution) 2.0 – 4.0
Individual Impurity NMT 0.5%
Total Impurities NMT 2.0%
Melting Point 150°C – 154°C
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