Powder: | Yes |
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Customized: | Customized |
Certification: | GMP, HSE, ISO 9001, USP, BP |
Suitable for: | Elderly, Children, Adult |
State: | White Powder |
Purity: | >99% |
Samples: |
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Customization: |
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items | Specifications | Results |
Appearance |
White or off-white crystalline powder |
Conforms |
HPLC |
The retention time of the major peaking the chromatogram of the sample corresponds to that exhibited by the working standard |
Conforms |
Loss on drying | No more than 1.0% | 0.40% |
Residue on Ignition | No more than 0.1% | 0.02% |
Heavy Metals | No more than 20ppm | <10ppm |
Related substances | Total impurities no more than 1.0% | 0.50% |
Single impurity no more than 0.5% | Conforms | |
Residual solvents | Eth yl ac etate No more than 0.1% | Conforms |
Ethanol No more than 0.1% | Conforms | |
Purity | No less than 99.0% | 99.50% |
Linagliptin was approved by the U.S. Food and Drug Administration (FDA) on 2 May 2011 for treatment of type II diabetes.
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