Gabapentin

Từ đồng nghĩa: 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.

Product Overview & Composition

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.

Key Applications

• 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.

Quality & Standards

Packaging & Supply

• Bao bì: 25 kg fiber drums with double polyethylene liners, or as per customer request.
• MOQ: 100 kg
• Thời gian thực hiện: 3-5 business days (stock items)
• Tài liệu hướng dẫn: COA, MSDS, TDS, and regulatory support available upon request.

Yêu cầu báo giá

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