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CERTIFICATE OF ANALYSIS
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Product Name |
Lamotrigine |
Batch No |
20221026 |
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Quantity |
20kg |
Assaying Date |
2022.10.26 |
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STANDARD |
USP40 |
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Test Items |
Specification |
Test Results |
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Appearance |
A White to pale cream-colored powder |
A White powder |
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Solubility |
Slight soluble in 0.1 N hydrochloric acid,in acetone,in methanol;insoluble in water |
Conforms |
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identification |
The infrared absorption spectrum corresponds to that of Lamotrigine Reference Standard |
Conforms |
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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 |
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Related Compounds(HPLC) |
Lamotrigine related compound C:NMT0.1% |
None detected |
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Lamotrigine related compound D:NMT0.2% |
None detected |
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Any individual unspecified impurity:NMT0.10% |
None detected |
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Total impurities,excluding Lamotrigine related compound B:NMT 0.2% |
None detected |
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Limit of Lamotrigine Related compound B |
NMT 0.1% |
None detected |
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Residual solvents(GC) |
Ethanol:NMT 3000 ppm |
48 ppm |
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Loss on drying |
NMT 0.5% |
0.06% |
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Residue on ignition |
NMT 0.1% |
0.05% |
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Heavy Metals |
NMT 0.001% |
＜0.001% |
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Assay (HPLC) |
NLT 98.0% & NMT 102.0% (calculated on the dried basis) |
99.8% |
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STORAGE |
Preserved in tight and light resistant container. Temperature≤30℃. |
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CONCLUSION |
The product complies with the specification of USP40. |
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