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 |
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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.
| 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 |
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