This certificate of analysis summarizes the results of quality testing on a batch of topiramate produced by Shandong Octagon Chemicals Limited. The tests show that the topiramate meets or exceeds standards for identification, purity, residual solvents, and assay according to USP40. The batch of 580.6 kg is certified as suitable for use and should be stored in a well-closed container at ambient temperature.

1. SHANDONG OCTAGON CHEMICALS LIMITED
CERTIFICATE OF ANALYSIS
TEL:0086-13071891945 FAX:0086-0535-6715688
Address: ROOM 5032,NO.9 YANAN ROAD,HANGZHOU,CHINA
sales@octagonchem.com
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Product name Topiramate (Cas 97240-79-4)
Batch No. 20200301 Mfg. date 2020.03.15
Rep. Date 2020.03.19 Exp. date 2022.03.14
Packaging 25kg/Drum Batch Size 580.6kg
Test Items Standards: USP40 Results
Appearance White to off-white powder White powder
Identification Should conform Conforms
Specific rotation -28.6°~ -35.0°, at 20°C -29.6°
Solubility Freely soluble in Dichloromethane Conforms
Water NNT0.5% 0.14%
Residue on Ignition NMT0.2% 0.11%
Heavy metals Not more than 10ppm <10ppm
Related compounds by
HPLC (Test 1)
Fructose:NMT 0.3%
Compound A: NMT 0.3%
Other individual impurity: 0.1%
Total impurities not more than 0.5%
0.11%
0.06%
0.095 %
0.265%
Limit of sulfamate
and sulfate
Sulfamate:NMT 0.10%;
Sulfate :NMT 0.10%.
ND
ND
Residual Solvents
1,2-dichloroethane: NMT5ppm
Pyridine: NMT200ppm
Acetone: NMT5000ppm
Ethanol: NMT5000ppm
MIBK: NMT5000ppm
<LOD
<LOD
0.0002%
0.018%
<LOD
Assay 98.0%~102.0% 99.1%
Conclusion It meets the requirements of USP40 Standards
Storage Store in a well-closed container at ambient temperature
Prepared by: LI Reviewed by: WEI Released by:Zhang