| Function: | Visceral System Medication |
|---|---|
| Grade Standard: | Medicine Grade |
| Type: | API |
| State: | Powder |
| Volatile: | Not Volatile |
| Standard: | USP42 |
| Samples: |
|---|
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| Product Name | Lamotrigine | CAS No. | 84057-84-1 | |
| Items | Standard | Results | ||
| APPEARANCE | A white to pale cream-colored powder | A white powder | ||
| SOLUBILITY | Slightly soluble in 0.1 N hydrochloric acid,in acetone, in methanol; insoluble in water | Conforms | ||
| IDENTIFICATION | The infrared absorption spectrum corresponds to that of Lamotrigine Reference Standard | Conforms | ||
| 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 | Conforms | |||
| RELATED COMPOUNDS (HPLC) | Lamotrigine related compound C: NMT 0.1% | None detected | ||
| Lamotrigine related compound D: NMT 0.2 % | None detected | |||
| Any individual unspecified impurity: NMT 0.10 % | None detected | |||
| Total impurities,excluding Lamotrigine related compound B: NMT 0.2 % | None detected | |||
| LIMIT OF LAMOTRIGINE RELATED COMPOUND B | NMT 0.1 % | None detected | ||
| RESIDUAL SOLVENTS (GC) | Ethanol: NMT 3000 ppm | 46 ppm | ||
| LOSS ON DRYING | NMT 0.5 % | 0.01% | ||
| RESIDUE ON IGNITION | NMT 0.1 % | 0.08% | ||
| ASSAY (HPLC) | NLT 98.0 % & NMT 102.0 % (calculated on the dried basis) | 99.5% | ||
| STORAGE | Preserved in tight and light resistant container. Temperature: ≤ 30°C | |||
| Conclusion | The product complies with the specification of USP42. | |||
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