Product Main

Specifications



Usage:
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 F 2α analogue that works by increasing the outflow of aqueous fluid from the eyes.
   




Specification sheet:

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.

Storage: Preserve at -25°C~-15°C in airtight and light-resistant containers.