Name:Lamotrigine
MF:C9H7Cl2N5
MW:256.09
CAS:84057-84-1
EINECS:281-901-8
Appearance: white or off-white powder
Assay:99%min
Packing:25kg/drumThe detailed specifications are as below:
| Appearance | A white to pale cream –colored power |
| Solubility | Slighly soluble in 0.1 N hydrochloric acid, in methanol, and in water |
| Identification | The infrared absorption spectrum corresponds to that of Lamotrigine Reference Standard |
| The retention time of major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay | |
| Related compoumds(HPLC) | Lamotrigine related compoundC: NMT 0.1% |
| Lamotrigine related compoundD: NMT 0.2% | |
| Any individual unspecified impurity:NMT 0.1% | |
| Total impurities, excluding Lamotrigine related compoundB:NMT 0.2% | |
| Limit of lamotrigineRelated compound B | NMT 0.1% |
| Residual solvents(GC) | Ethanol: NMT 3000 ppm |
| Loss on drying | NMT 0.5% |
| Residue on ignition | NMT 0.1% |
| Heavy metals | NMT 0.001% |
| Assay(HPLC) | NLT 98% & NMT 102.0%(calculated on the dried basis ) |