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Travoprost Manufacture Prostaglandins
Tests |
Specifications |
Results |
Appearance |
Colorless to yellowish viscous oily liquid |
Yellowish viscous oily liquid |
Identification |
|
|
By TLC |
The Travoprost should be appear as Black Spots. |
Conforms |
By HPLC |
The Retention time of the maior peak in the chromatogram of the test preparation corresponding to that in the chromatogram of the standard preparation, as per Assay test. |
Conforms |
Specific Rotation |
[α]20D: +52.0° ~ +58.0°at 365nm |
55.3° |
Water |
N.M.T.1.0 % |
0.2% |
Limit of ethyl acetate |
N.M.T. 5000ppm |
1400ppm |
Travoprost Related compound A |
N.M.T. 0.2% |
N.D. |
15-epi Diasteromer |
N.M.T. 0.5% |
0.18% |
5,6-trans Isomer |
N.M.T. 3.5% |
0.80% |
15-Keto derivative |
N.M.T. 0.3% |
N.D. |
Any other impurity |
N.M.T. 0.1% |
0.09% |
Total impurities |
N.M.T. 4.0% |
1.2% |
Assay: Travoprost |
96.0% ~ 102%(C26H35F3O6) |
98.4% |
Conclusion |
Conform to USP37 |
our quality system
we has a sound quality management system and documents, equipped with shimadzu hplc, gc chromatography and other series of testing equipment, in order to meet the quality priority principle. quality management department is independent of the production system, and execute with quality inspection and quality supervision, quality management functions.
the qa department is responsible for establishing and perfecting the quality supervision system, and set up the qa personnel from supplier evaluation of material, raw material procurement, warehousing acceptance, production, release, sales, customer feedback to monitor the whole process, further standardize and improve the quality management system; at the same time, we do on-site inspection and regular quality report and other means to manage the quality system, and regularly organize gmp training to update employee’s knowledge and improve the quality concept. we are strictly implementing gmp management, and are open to accept external customer audit and official inspections.
our r & d
we use the advantage of combination of chemical synthesis and purification technology platform, to carry out research and development of various apis and intermediates with high degree of difficulty, especially chiral drugs.
our r & d team has more than 5 year-experience in r & d and scale production of prostaglandins, anti-cancer drugs and hypoglycemic drugs. all of these products have achieved commercial production, and occupied a leading position in the market competition.
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