- Min.Order :0 Metric Ton
- Purity: 99%
- Payment Terms : L/C,T/T
Keywords
Latanoprost Genriver Prostaglandins
Quick Details
- Appearance:pale yellow Oil
- Application:eye drops, anti-glaucoma
- PackAge:1g/package, 5g/package, 10g/package, 100g/package
- ProductionCapacity:200|Gram|Month
- Storage:Store in dry, dark and ventilated place
- Transportation:room temperature
Superiority:
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Storage |
Preserve at 2℃~8 ℃ in airtight and light resistant containers |
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Quality Specification |
USP |
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Tests |
Specifications |
Results |
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Appearance |
Colorless to pale yellow viscous oily liquid |
Conforms |
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Solubility |
Very soluble in Acetonitrile, freely soluble in Ethyl acetate and in Ethanol, practically insoluble in water |
Conforms |
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Identification |
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 |
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IR |
The IR Spectrum of the same should be consistent with that of the reference standard. |
Conforms |
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Optical rotation |
+31.0° ~ +38.0° (10mg/ml of Latanoprost in acetonitrile) |
+33.8° |
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Residue on ignition |
NMT 0.5% |
0.05% |
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Water |
N.M.T.2.0% |
0.08% |
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Residual solvents |
Ethanol |
N.M.T. 0.5% |
0.20% |
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n-Hexane |
N.M.T. 0.029% |
Not detected |
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Related Substances |
Isopropyl diphenylpho- sphorylpentanoate |
N.M.T. 0.1% |
Not detected |
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Latanoprost related compound B |
N.M.T. 0.5% |
Not detected |
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Latanoprost related compound A |
N.M.T. 3.5% |
Not detected |
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Any unspecified impurity |
N.M.T. 0.1% |
0.091% |
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Total impurities |
N.M.T.0.5% |
0.15% |
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Latanoprost related compound E |
N.M.T. 0.2% |
Not detected |
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Assay |
94.0~102.0% (calculated on the anhydrous and solvent-free basis) |
99.5% |
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Conclusion |
Conform to USP |
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Details:
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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