Lamotrigine

Lamotrigine

Tên sản phẩm Lamotrigine
Số CAS 84057-84-1
Công thức phân tử C9H7Cl2N5
Trọng lượng phân tử 256.09 g/mol
Hình thức Bột tinh thể màu trắng đến trắng ngà
Phương pháp phân tích (HPLC) 98.0% – 102.0%
Điểm nóng chảy 216–218 °C
Độ hòa tan Sparingly soluble in water; soluble in dimethyl sulfoxide, dimethylformamide
Gói 25 kg fiber drum with double polyethylene liner

Lamotrigine Structure

Từ đồng nghĩa: 3,5-Diamino-6-(2,3-dichlorophenyl)-1,2,4-triazine, Lamictal, LTG, BW-430C, 6-(2,3-Dichlorophenyl)-1,2,4-triazine-3,5-diamine

Lamotrigine is a phenyltriazine derivative that has carved out a distinct place in the anticonvulsant and mood-stabilizer markets since its approval in the 1990s. Unlike older antiepileptics that emerged from serendipitous screening, lamotrigine was designed to inhibit glutamate release—a mechanism that translates into broad-spectrum efficacy across partial and generalized seizures. For procurement teams, it represents a reliable, well-characterized API with steady demand from both generic and branded formulators.

From a chemical standpoint, lamotrigine is a small molecule (C9H7Cl2N5) with a dichlorophenyl ring attached to a diaminotriazine core. This structure gives it moderate lipophilicity and a low aqueous solubility, which formulators often address through salt formation or particle-size engineering. The compound is chemically stable under normal storage conditions, though it is light-sensitive and should be protected from prolonged exposure to strong UV light.

Manufacturing lamotrigine at commercial scale typically involves a multi-step synthesis starting from 2,3-dichlorobenzoyl chloride or related precursors. The critical quality attributes—assay, related substances, and residual solvents—are tightly controlled to meet pharmacopeial monographs (USP, EP, BP). Our material is produced under cGMP conditions and is available with full regulatory support, including DMF and CEP where applicable.

While lamotrigine is best known for epilepsy, its use in bipolar disorder—particularly for delaying depressive episodes—has expanded its clinical footprint. This dual indication keeps demand stable across multiple therapeutic categories, making it a strategic API for companies serving both neurology and psychiatry markets.

Chức năng

  • Anticonvulsant activity: Blocks voltage-gated sodium channels, stabilizing neuronal membranes and reducing seizure spread.
  • Glutamate inhibition: Suppresses excessive glutamate release, which contributes to its broad-spectrum efficacy.
  • Mood stabilization: Effective in delaying depressive episodes in bipolar I disorder, likely through limbic system modulation.
  • Neuroprotective potential: Under investigation for conditions involving glutamate excitotoxicity, such as neuropathic pain.

Nguồn gốc và tiêu chuẩn hóa

  • Nguồn: Synthetic chemical synthesis (not botanical)
  • Tiêu chuẩn hóa: Complies with USP/EP/BP monographs; assay 98.0–102.0% (HPLC)
  • Forms: White to off-white crystalline powder
  • Ứng dụng: Antiepileptic and mood-stabilizer finished dosage forms

Thông số kỹ thuật

Tham số Thông số kỹ thuật
Assay (HPLC, dried basis) 98.0% – 102.0%
Xác định IR, UV conforms to reference standard
Mất mát khi sấy khô ≤ 0,5%
Hàm lượng tro sau khi đốt ≤ 0,1%
Kim loại nặng ≤ 20 ppm
Các chất liên quan Total impurities ≤ 0.5%; each unspecified ≤ 0.1%
Chất dung môi còn lại Meets USP / EP 5.4 requirements

Documentation & Supply

  • Công suất hàng tháng: 2–3 metric tons
  • Thời gian thực hiện: 3-5 business days (stock items)
  • Tài liệu hướng dẫn: COA, MSDS, TDS, DMF (where applicable), stability data
  • Bao bì: 25 kg fiber drum with double polyethylene liner, or as requested

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