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Travoprost ophthalmic solution is a topical medication used for controlling the progression of glaucoma or ocular hypertension, by reducing intraocular pressure. It is a synthetic prostaglandin analog (or more specifically, an analog of prostaglandin F2α) that works by increasing the outflow of aqueous fluid from the eyes.
Specification:
|
Items |
Specifications |
Results |
|
Appearance |
Clear colorless to light yellow oily liquid |
Conforms |
|
Solubility |
Very souble in acetonitrile and ethanol, practically insoluble in water |
Conforms |
|
Identification |
TLC: appear as black spots HPLC: the retention time of the major peak in the chromatogram of assay preparation corresponds to that of the standard preparation as obtained in the assay. |
Conforms Conforms |
|
Optical rotation |
+52.0°~+58.0° (anhydrous and solvent free basis) |
+53.6° |
|
Water |
NMT 1.0% |
0.1% |
|
Residual solvents |
Ethyl acetate: NMT 0.5% |
ND |
|
Related substances |
USP travoprost related compound A RS: NMT 0.2% Epoxide derivative : NMT 0.4% 15-epi Diastereomer: NMT 0.1% 5,6-trans Isomer: NMT 3.5% 15-Keto derivative: NMT 0.3% Any other individual impurity: NMT 0.1% Total impurities: NMT 4.0% |
ND 0.01% 0.01% ND 0.01% ND 0.02% |
|
Assay |
96.0%~102.0% (anhydrous and solvent free basis) |
98.9% |
|
Conclusion |
Conform to Enterprise standard. |
|
Packaging details:
|
Packaging details: |
25kg/drum with double plastic bags inside; packed in a cardboard drum or fiber HDPE drum. |
|
Storage: |
Stored in a clean, cool, dry area; keep away from moisture and strong, direct light/heat |
|
Shelf Life: |
5 years if sealed and store away from direct sun light. |
