Antiepileptic Pharmaceutical Raw Materials Lamotrigine CAS 84057-84-1 For Treatment of Epilepsy And Bipolar Disorder
Superiority
Zhongshan Latterson Biotechnology Co., Ltd., is a comprehensive pharmaceutical enterprise, which specialized in bio-pharmaceutical technology over 7 years. The company is located in Zhongshan City, Guangdong Province , China.
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Product Name |
Lamotrigine |
Synonyms |
4-Triazine-3,5-Diamine,6-(2,3-Dichlorophenyl)-2;
3,5-Diamino-6-(2,3-Dichlorophenyl)-1,2,4-Triazine;
6-(2,3-Dichlorophenyl)-1,2,4-Triazine-3,5-Diamine;Lamictal;Lamotrigin |
CAS |
84057-84-1 |
MF |
C9H7Cl2N5 |
MW |
256.09 |
EINECS |
281-901-8 |
Chemical Properties |
White to Cream Coloured Powder |
Category |
API |
Melting point |
177-181ºC |
Quality Standard |
EP/USP |
Place Of Origin |
China |
Application |
Pharmaceutical raw materials |
Description:
Lamotrigine, originally marketed as Lamictal and available under many brands worldwide, is an anticonvulsant drug used in the treatment of epilepsy and bipolar disorder. It is also used off-label as an adjunct in treating clinical depression.
For epilepsy, it is used to treat focal seizures, primary and secondary tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome. Like many other anticonvulsant medications, lamotrigine also seems to act as an effective mood stabilizer, and has been the first US Food and Drug Administration (FDA)-approved drug for this purpose since lithium, a drug approved almost 30 years earlier. It is approved for the maintenance treatment of bipolar type II.
Lamotrigine is a synthetic phenyltriazine with anti-epileptic and analgesic properties. Lamotrigine enhances the action of gamma-aminobutyric acid (GABA), an inhibitory neurotransmitter, which may result in a reduction of pain-related transmission of signals along nerve fibers. This agent may also inhibit voltage-gated sodium channels, suppress glutamate release, and inhibit serotonin reuptake.
It is generally accepted to be a member of the sodium channel blocking class of antiepileptic drugs, but it could have additional actions since it has a broader spectrum of action than other sodium channel antiepileptic drugs such as phenytoin and carbamazepine and is effective in the treatment of the depressed phase of bipolar disorder, whereas other sodium channel blocking antiepileptic drugs are not, possibly on account of its sigma receptor activity. In addition, lamotrigine shares few side-effects with other, unrelated anticonvulsants known to inhibit sodium channels, which further emphasises its unique properties. Lamotrigine is inactivated by glucuronidation in the liver .
Application:
For the adjunctive treatment of partial seizures in epilepsy and generalized seizures of Lennox-Gastaut syndrome. Also for the maintenance treatment of bipolar I disorder and depression.
Biological Activity:Anticonvulsant. Inhibits glutamate release, possibly through inhibition of Na + , K + and Ca 2+ currents.
Lamotrigine Medical uses
Epilepsy
Lamotrigine is approved in the US for the treatment of partial seizures. It is considered a first-line drug for primary generalised tonic-clonic seizures (includes simple partial, complex partial and secondarily generalised seizures), and as an adjuvant therapy in partial seizures (focal onset tonic-clonic, atypical absence, myoclonic, and due to Lennox-Gastaut syndrome). As well, it is used as an alternative drug for absence seizure and atypical absence, myoclonic, and atonic seizures.
Lamotrigine is one of a small number of FDA-approved therapies for seizures associated with Lennox-Gastaut syndrome, a severe form of epilepsy. Typically developing before four years of age, LGS is associated with developmental delays. There is no cure, treatment is often complicated, and complete recovery is rare. Symptoms include the atonic seizure (also known as a “drop attack”), during which brief loss of muscle tone and consciousness cause abrupt falls. Lamotrigine significantly reduces the frequency of LGS seizures, and is one of two medications known to decrease the severity of drop attacks.Combination with valproate is common, but this increases the risk of lamotrigine-induced rash, and necessitates reduced dosing due to the interaction of these drugs.
Bipolar disorder
Lamotrigine is approved in the US for maintenance treatment of bipolar I disorder. While traditional anticonvulsant drugs are predominantly antimanics, lamotrigine is most effective for preventing the recurrent depressive episodes of bipolar disorder. The drug seems ineffective in the maintenance of current rapid-cycling, acute mania, or acute depression in bipolar disorder; however, it is effective at prevention of or delaying the mania, depressive, or rapid cycle. According to studies in 2007, lamotrigine may treat bipolar depression without triggering mania, hypomania, mixed states, or rapid-cycling.
COA:
Item |
Requirements |
Test Results |
Description |
A white or almost white crystalline powder |
Complies |
Solubility |
Soluble in methanol, very slightly soluble in acetone and isopropanol . |
Complies |
Melting point |
215°C~ 219°C |
217°C~218°C |
Appearance of solution |
5.0% solution in DMF should be clear |
Complies |
Loss on drying |
≤ 0.5% |
0.03% |
Residue on ignition |
≤ 0.1% |
0.04% |
Heavy metals |
≤ 20ppm |
Complies |
Residual solvent |
|
|
Methanol |
≤ 1000ppm |
Complies |
Ethanol |
≤ 1000ppm |
Complies |
Any other individual impurity: |
≤ 0.1% |
Complies |
Total impurities |
≤ 1.0% |
Complies |
Assay |
99.0%-101.0% |
99.70% |
Conclusion |
Meets the Requirements |
Our service
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