Product Name

Lamotrigine

Batch No

20221026

Quantity  

20kg

Assaying Date

2022.10.26

STANDARD

USP40

Test Items

Specification

Test Results

Appearance

A White to pale cream-colored powder

A White powder  

Solubility

Slight 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:NMT0.1%

None detected

Lamotrigine related compound D:NMT0.2%

None detected

Any individual unspecified impurity:NMT0.10%

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

48 ppm

Loss on drying

NMT 0.5%

0.06%

Residue on ignition

NMT 0.1%

0.05%

Heavy Metals

NMT 0.001%

＜0.001%

Assay (HPLC)

NLT 98.0% & NMT 102.0% (calculated on the dried basis)

99.8%

STORAGE

Preserved in tight and light resistant container.

Temperature≤30℃.

CONCLUSION

The product complies with the specification of USP40.