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CERTIFICATE OF ANALYSIS
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Product Name |
Galanthamine Hydrobromide [4as,6R,8as]-4a,5,9,10,11,12-Hexah ydro-3-Methoxy-11-Methyl-6H-Benzo furo [3a,3,2-ef][2] Benzazepin-6-OL Hydrobromide |
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Molecular Formula |
C17H22BrNO3 |
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Cas No. |
1953-04-4 |
Quantity |
21.3 kg |
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MFG. Date |
2022.01.07 |
Batch No |
20220107 |
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Report Date |
2022.01.11 |
Retest. Date |
2024.01.06 |
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Testing Items |
Specifications |
Results |
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Description |
White to almost white powder |
Conforms |
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Solubility |
Soluble in 0.1N sodium hydroxide, sparingly soluble in water, very slightly soluble in alcohol, insoluble in n-propanol. |
Conforms |
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Identification |
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By 1HNMR |
Conforms to structure |
Conforms |
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By HPLC |
The retention time of the major peak as obtained in the “Limit of Galanthamine enantiomer[(+)- Galanthamine]test”of the sample solution should correspond to that of the Galanthamine peak in the system suitability solution. |
Conforms |
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Test for Bromide |
A yellow precipitate is formed indicating the presence of bromide ions. |
Conforms |
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Loss on Drying (%w/w, determined on 1.0g at 105°C for 4h) |
Not more than 0.5% |
0.14% |
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Residue on Ignition (%w/w, determined on 1.0g) |
Not more than 0.1% |
0.03% |
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Heavy Metals |
Not more than 20 PPM |
Less than 10 PPM |
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Limit Of Galanthamine Enantiomer (+)-Galanthamine] (By HPLC,%w/w) |
Not more than 0.01% |
Not detected |
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Related Substances (By HPLC, % w/w) |
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Norgalanthamine[USP: N-Desmethylgalantamine] |
Not more than 0.20% |
Not detected |
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Lycoramine [USP:Dihydrogalantamine] |
Not more than 0.35% |
0.17% |
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Glanthamine N-oxide [USP: Glanthamine N-Oxide] |
Not more than 0.20% |
Not detected |
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Epigalanthamine[USP: 6S-Galantamine] |
Not more than 0.20% |
0.04% |
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Dehydroxygalanthamine [USP:Didehydrodeoxygalantamine] |
Not more than 0.40% |
0.05% |
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O-Desmethylgalanthamine |
Not more than 0.20% |
Not detected |
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Narwedine |
Not more than 0.15% |
Not detected |
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Any other |
Not more than 0.10% |
0.02% |
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Total |
Not more than 1.0% |
0.32% |
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Assay (By HPLC, %w/w, as C17H22BrNO3, on dried basis) |
Not less than 98.0% and Not more than 102.0% |
99.68% |
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Residual Solvents(By GC, µg/g) |
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Toluene |
Not more than 890 |
Not detected |
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Ethanol |
Not more than 5000 |
254 |
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Tetrahydrofuran |
Not more than 500 |
Not detected |
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Bromide Content (By Titrimetry, %w/w,on as is basis) |
Between 20.6 %and 22.8% |
21.5% |
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Particle Size (By Malvern Particle size analyzer, µm) |
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D(v,0.1) |
Report results |
22 |
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D(v,0.5) |
87 |
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D(v,0.9) |
164 |
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Conclusion |
This product conforms to USP30 standard |
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Remark: The material complies as per the above specification of USP30
