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Dydrogesterone
Dydrogesterone
CAS No.:152-62-5
Molecular Formula:C21H28O2
Molecular Weight:312.45
PRODUCT NAME:Dydrogesterone

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

Items

Specifications

Results

1.Appearance:

White or almost white, crystalline

powder

Almost white crystalline powder

2. Solubility

Practically insoluble in water, soluble in acetone, sparingly soluble 

in ethanol(96%)

Complies

 

 

3.Identification:

A: IR: IR spectrum of sample corresponds to that of reference standard

Complies

B: HPLC: The retention time obtained from the sample solution corresponds

 to the retention  time from the standard solution

 

Complies

 

 

4.Related substances:

Impurity A:0.10% Max.

0.002%

lmpurity B:0.10% Max.

Not detected

Impurity C: 0.3% Max.

0.005%

Any unspecified impurity: 0.10% Max.

Not detected

Sum of impurities:0.5% Max.

0.007%

5. Loss on drying:

0.5%  Max.

0.06%

6.Residue on ignition:

0.1%  Max

0.05%

7.Heavy metals:

10ppm  Max.

<10ppm

8.Assay:

98.0% to 102.0%

99.9%

 

 

 

 

 

9.Residual solvents:

Acetone:0.5%  Max.

0.008%

Heptane:0.5%  Max.

0.002%

Tetrahydrofuran:0.072% Max.

Not detected

Triethylamine:0.5% Max.

Not detected

Methanol: 0.3% Max.

0.005%

Ethanol: 0.5% Max.

Not detected

Dichloromethane: 0.06% Max.

Not detected

Ethyl acetate: 0.5% Max.

Not detected

Methyl acetate:0.5% Max.

Not detected

Glycol:0.062% Max.

Not detected

10.Total aerobic

microbial count:

103cfu/g Max.

<101cfu/g

11.Mold &Yeast:

102cfu/g Max

<10¹cfu/g

12.BTGN bacteria:

Negative(N<10)

N<10

*13.Particle  size:

90%  pass  10μm

Complies

Conclusion: The above product conforms to EP10.8.

 

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