Lubiprostone Genriver Prostaglandins
Tests |
Specifications |
Results |
Appearance |
white or off white crystalline powder |
Conforms |
Solubility |
Insoluble in water and n-hexane, soluble in methanol, acetone, alcohol, ethyl acetated and dichloromethane |
Conforms |
Identification(HPLC) |
Retention time matches with the reference |
Complies |
Optical rotation |
[α]20D: - 42.0º ~ - 48.0º (10mg/ml, in methanol, 100mm) |
-45.4° |
Water |
N.M.T.0.5 % |
0.12% |
Residual solvents |
Ethyl Acetate:N.M.T. 0.5% |
0.21% |
|
n-Heptane : N.M.T. 0.5% |
0.18% |
Heavy metals |
N.M.T.0.002 % |
Conforms |
Purity (HPLC) |
Related impurity(except tautomer): N.M.T. 0.5% |
0.04% |
|
Total impurity N.M.T. 0.5% |
0.08% |
Assay |
99.0%-101.0% |
99.4% |
Conclusion |
Conform to Enterprise Standard |
Shanghai Genriver Pharmaceutical Technology Co., Ltd. is located in Songjang Industrial Park in Shanghai City, it is founded by domestic senior experts and pharmaceutical sales staff, is a high-tech enterprises integrated with research and development, production and sales, import and export trade business.
Shanghai Genriver Pharmaceutical Technology Co., Ltd. is a technology oriented company, see the quality as our life and dedicated to meet the customer’s requirement and provides a full range of services to customers as per GMP compliance, such as customized manufacturing, technology consultation, documentation services.
Based on the chemical synthesis and purification technology platform, we have a high level R&D standard laboratory for synthesis and also a multiple-function pilot production workshop and equipped with a full set of testing facilities.
We always adhere to the "credibility first, quality first" corporate creed, see the quality as life, and implementing GMP management, to provide customers with comprehensive services.
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