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Product Name |
Travoprost |
Batch No. |
20130222 |
Manufacture Date |
2013.02.22 |
Analysis Date |
2013.02.25 |
Molecular Formula |
C26H35F3O6 |
Molecular Weight |
500.55 |
CAS No. |
157283-68-6 |
TESTS |
SPECIFICATIONS |
RESULTS |
Appearance |
A pale yellow to colorless Oil |
A colorless Oil |
Identification |
TLC;HPLC |
Complies |
Specific Rotation |
+52°~ +58° |
+53.89° |
Water |
≤1.0% |
0.25% |
Related compounds |
15-epi Diastereomer≤0.1% |
0.04% |
5,6-trans Isomer≤3.5% |
0.24% |
|
Epoxide derivative≤0.4% |
Not detectable |
|
15-Keto derivative≤0.3% |
0.07% |
|
Any other impurity≤0.1 % |
0.02% |
|
Total other impurities≤1.0 % |
0.05% |
|
Residue solvent |
Isopropanol≤0.5 % |
0.1% |
Ethyl acetate≤0.25 % |
Not detectable |
|
n-Hexane:≤0.029% |
Not detectable |
|
Ethanol≤0.5 % |
0.35% |
|
Purity(HPLC) |
> 99.0% |
99.61% |
Conclusion |
The product meets the requirements of USP34 |
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