Dydrogesterone is a synthetic progestin hormone used primarily in the treatment of various gynecological conditions. It mimics the actions of the natural hormone progesterone, making it an effective therapeutic option for several women's health issues.
Dydrogesterone is available in oral tablet form and is prescribed by healthcare providers to address specific medical conditions related to hormonal imbalances or deficiencies.
Key uses and benefits of Dydrogesterone:
1:Menstrual Disorders: Dydrogesterone is commonly prescribed to treat irregular or painful menstrual cycles. It helps regulate the menstrual cycle and can be used to manage conditions like dysmenorrhea (painful periods) and irregular menstrual bleeding.
2:Hormone Replacement Therapy (HRT): For women undergoing hormone replacement therapy, Dydrogesterone may be used in combination with estrogen to protect the uterine lining from overgrowth and reduce the risk of endometrial hyperplasia (excessive thickening of the uterine lining).
3:Assisted Reproduction: In assisted reproductive technologies, such as in vitro fertilization (IVF), Dydrogesterone may be used to support pregnancy by preparing the uterine lining for embryo implantation and maintaining the early stages of pregnancy.
4:Threatened Miscarriage: Dydrogesterone is sometimes prescribed in cases of threatened miscarriage to support the pregnancy and reduce the risk of pregnancy loss.
5:Premenstrual Syndrome (PMS): Dydrogesterone may be beneficial for some women in managing symptoms associated with premenstrual syndrome, such as bloating, mood swings, and breast tenderness.
Product name: |
Dydrogesterone |
Batch No.: |
20230201 |
Quantity: |
5kg |
Packaging: |
5kg/carton |
Manuf. date: |
Feb. 24,2023 |
Sampling Date: |
Mar. 23, 2023 |
Retest date: |
Feb. 23,2026 |
Report date: |
July 11,2023 |
Standard: |
EP10.8 |
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Items |
Specifications |
Results |
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1.Appearance: |
White or almost white, crystalline powder |
Almost white crystalline powder |
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2. Solubility |
Practically insoluble in water, soluble in acetone, sparingly soluble in ethanol(96%) |
Complies |
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3.Identification: |
A: IR: IR spectrum of sample corresponds to that of reference standard |
Complies |
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B: HPLC: The retention time obtained from the sample solution corresponds to the retention time from the standard solution |
Complies |
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4.Related substances: |
Impurity A:0.10% Max. |
0.002% |
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lmpurity B:0.10% Max. |
Not detected |
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Impurity C: 0.3% Max. |
0.005% |
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Any unspecified impurity: 0.10% Max. |
Not detected |
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Sum of impurities:0.5% Max. |
0.007% |
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5. Loss on drying: |
0.5% Max. |
0.06% |
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6.Residue on ignition: |
0.1% Max |
0.05% |
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7.Heavy metals: |
10ppm Max. |
<10ppm |
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8.Assay: |
98.0% to 102.0% |
99.9% |
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9.Residual solvents: |
Acetone:0.5% Max. |
0.008% |
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Heptane:0.5% Max. |
0.002% |
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Tetrahydrofuran:0.072% Max. |
Not detected |
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Triethylamine:0.5% Max. |
Not detected |
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Methanol: 0.3% Max. |
0.005% |
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Ethanol: 0.5% Max. |
Not detected |
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Dichloromethane: 0.06% Max. |
Not detected |
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Ethyl acetate: 0.5% Max. |
Not detected |
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Methyl acetate:0.5% Max. |
Not detected |
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Glycol:0.062% Max. |
Not detected |
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10.Total aerobic microbial count: |
103cfu/g Max. |
<101cfu/g |
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11.Mold &Yeast: |
102cfu/g Max |
<10¹cfu/g |
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12.BTGN bacteria: |
Negative(N<10) |
N<10 |
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*13.Particle size: |
90% pass 10μm |
Complies |
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Conclusion: The above product conforms to EP10.8. |
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