Gabapentin Enacarbil API Manufacturer in India

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Gabapentin Enacarbil API Manufacturer and Bulk Supplier in India

Gabapentin Enacarbil API (CAS No: 478296-72-9)

Gabapentin Prodrug API for Extended-Release Neurological Pharmaceutical Formulations

Gabapentin Enacarbil API (CAS No. 478296-72-9) is a transport-enabled prodrug of gabapentin associated with extended-release neurological pharmaceutical formulations. It was developed to provide improved and more predictable absorption characteristics compared with conventional gabapentin.

Following oral administration, Gabapentin Enacarbil is converted to gabapentin through hydrolysis. The therapeutic pharmacological activity of Gabapentin Enacarbil is therefore associated with the released gabapentin.

Gabapentin interacts with the α2δ auxiliary subunit of voltage-gated calcium channels and is associated with modulation of neuronal calcium-channel activity and neurotransmitter release pathways.

Pharmaceutical companies sourcing Gabapentin Enacarbil API commonly evaluate assay, HPLC purity, stereochemical and structural identity, related substances, process impurities, degradation products, residual solvents, water content, solid-state characteristics, particle size distribution, and batch-to-batch consistency.

Because Gabapentin Enacarbil is a prodrug containing hydrolysable functional groups, API manufacturers and formulation companies should carefully evaluate hydrolytic degradation, moisture exposure, temperature conditions, and impurity formation according to the approved product specification and stability program.

Swapnroop Drugs and Pharmaceuticals supplies Gabapentin Enacarbil API for pharmaceutical research, formulation development, generic drug development, analytical requirements, and regulated manufacturing applications with product-specific documentation, pharmaceutical-grade packaging, and reliable supply-chain coordination.

Critical Quality Requirements for Gabapentin Enacarbil API

Pharmaceutical companies evaluating Gabapentin Enacarbil API commonly focus on:

  • HPLC assay and chromatographic purity
  • Structural identification
  • Related substances
  • Process-related impurity control
  • Degradation impurity monitoring
  • Hydrolysis-related impurity control
  • Residual solvent profile
  • Water and moisture content
  • Elemental impurity assessment
  • Solid-state characteristics
  • Particle size distribution
  • Bulk density
  • Batch-to-batch consistency
  • Stability under recommended storage conditions

Moisture and hydrolytic stability are important considerations during API qualification because degradation of the prodrug structure may affect the API impurity profile and pharmaceutical quality.

Key Features

  • Gabapentin Enacarbil API CAS No. 478296-72-9
  • Transport-enabled prodrug of gabapentin
  • Pharmaceutical active ingredient for neurological product development
  • Development code XP13512
  • Molecular formula C16H27NO6
  • Molecular weight 329.39 g/mol
  • Controlled HPLC purity profile
  • Related substances monitored according to approved specification
  • Hydrolysis-related impurity monitoring
  • Residual solvents controlled according to applicable ICH Q3C requirements
  • Elemental impurities evaluated according to applicable ICH Q3D requirements
  • Particle size requirements coordinated as applicable
  • Pharmaceutical-grade packaging
  • COA and MSDS available as applicable
  • Bulk pharmaceutical supply and export support
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