| Customization: | Available |
|---|---|
| Powder: | Yes |
| Customized: | Customized |
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Dienogest is used primarily as a contraceptive in combination with ethinylestradiol. It is given as a tablet containing 2 mg of dienogest and 30 μg of ethinylestradiol. Dienogest is also available in a quadriphasic oral contraceptive pill combined with estradiol valerate, marketed as Natazia in the United States and Qlaira in some European countries and Russia. This formulation is also approved for the treatment of heavy menstrual bleeding.
| Item | Test Standard | Testing Result | |
| Appearance | Powder | Complies | |
| Color | White fine Powder | Complies | |
| Particle Size | 100% pass 80 mesh | Complies | |
| Oder | Characteristic | Complies | |
| Taste | Characteristic | Complies | |
| Loss on Drying | ≤5.0% | 2.20% | |
| Residue on Ignition | ≤0.1% | 0.05% | |
| Residual a'cetone | ≤0.1% | Complies | |
| Residual Ethanol | ≤0.5% | Complies | |
| Heave Mentals | ≤10ppm | Complies | |
| Na | ≤0.1% | <0.1% | |
| Pb | ≤3 ppm | Complies | |
| Total Plate | <1000CFU/g | Complies | |
| Yeast & Mold | <100 CFU /g | Complies | |
| E. Coli | Negative | Complies | |
| Salmonella | Negative | Complies | |
| Conclusion: Conform with USP Standard | |||
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