Gabapentin

Gabapentin

Nombre del producto Gabapentin
Número CAS 60142-96-3
Fórmula molecular C9H17NO2
Peso molecular 171.24 g/mol
Apariencia Polvo cristalino de color blanco a blanquecino
Ensayo (HPLC) 98.0% – 102.0%
Pérdida por secado ≤ 0,51 TP3T
Residuo tras la combustión ≤ 0,11 TP3T
Metales pesados ≤ 10 ppm
Solubilidad Soluble in water, slightly soluble in ethanol
Paquete 25 kg fiber drum with double PE liner

Gabapentin Structure

Sinónimos: 1-(Aminomethyl)cyclohexaneacetic acid, Neurontin, Gabapentin, 2-[1-(Aminomethyl)cyclohexyl]acetic acid, CI-945, GOE-3450

Gabapentin has firmly established itself as a key API in the pharmaceutical industry, particularly for neurological and pain management therapies. Its unique mechanism of action and favorable safety profile have driven steady demand across both prescription and research sectors. As generic formulations expand and new therapeutic applications emerge, procurement teams are increasingly focused on securing reliable, high-purity gabapentin from qualified suppliers.

Gabapentin is a synthetic gamma-aminobutyric acid (GABA) analog, structurally distinct from endogenous GABA but capable of modulating neuronal excitability. It is synthesized through a multi-step chemical process, yielding a white to off-white crystalline powder that is freely soluble in water. The compound’s stability and bioavailability make it suitable for oral solid dosage forms, including tablets and capsules.

Commercial gabapentin is typically standardized to 98.0%–102.0% assay (HPLC), meeting pharmacopeial requirements such as USP and EP. Manufacturers and formulators value its consistent particle size distribution and low impurity profile, which facilitate robust tablet compression and uniform content uniformity. With patent expirations and growing generic competition, the focus has shifted to supply chain reliability, documentation transparency, and cost efficiency.

Descripción general y composición del producto

Gabapentin is a white to off-white crystalline powder with a molecular weight of 171.24 g/mol. It is chemically designated as 1-(aminomethyl)cyclohexaneacetic acid and is freely soluble in water, with slight solubility in ethanol. The compound is stable under normal storage conditions and is compatible with common excipients used in solid dosage forms.

Its structure incorporates a cyclohexane ring and an amino acid moiety, which contributes to its lipophilic character and ability to cross the blood-brain barrier. The active pharmaceutical ingredient (API) is typically produced via chemical synthesis, followed by purification steps to achieve high purity and consistent quality.

Aplicaciones principales

  • Antiepileptic formulations: Used as an adjunctive therapy for partial seizures in adults and children.
  • Neuropathic pain management: Prescribed for postherpetic neuralgia and other neuropathic pain conditions.
  • Research applications: Studied for its effects on calcium channels and potential in treating anxiety, mood disorders, and sleep disturbances.
  • Generic drug manufacturing: A key API for generic gabapentin capsules and tablets, meeting USP/EP standards.
  • Veterinary medicine: Used in companion animals for seizure control and pain relief.

Calidad y normas

Parámetro Especificaciones
Ensayo (HPLC) 98.0% – 102.0%
Pérdida por secado ≤ 0,51 TP3T
Metales pesados ≤ 10 ppm
Residuo tras la combustión ≤ 0,11 TP3T
Límites microbianos Total aerobic count ≤ 1000 CFU/g
Impurities Meets USP/EP requirements

Embalaje y suministros

  • Embalaje: 25 kg fiber drums with double polyethylene liners, or as per customer request.
  • Cantidad mínima de pedido: 100 kg
  • Plazo de entrega: 3-5 días laborables (artículos en stock)
  • Documentación: COA, MSDS, TDS, and regulatory support available upon request.

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