Product Information |
Product name |
Promestriene; Promestrienum |
CAS No. |
39219-28-8 |
Molecular Formula |
C22H32O2 |
Molecular Weight |
328.495 |
Quality Standard |
99% up by HPLC |
Appearance |
White crystalline powder |
COA |
ANALYSIS |
SPECIFICATION |
RESULTS |
Appearance |
White crystalline powder |
|
Identification |
IR: The IR chromatogram of the test substance should be identical with that of the reference standard. |
Conforms |
Melting point: 64°C~ 68°C |
65.7°C~ 66.7°C |
|
Specific rotation: +62°~ 68° |
+63° |
|
Loss on drying |
<0.5% |
0.06% |
Residue on ignition |
<0.1% |
0.05% |
Heavy metals |
<10ppm |
<10ppm |
Related substances |
Individual impurity < 0.10% Total impurities < 0.5% |
Maximum individual impurity: 0.03% Total impurities: 0.03% |
Residual solvents |
Methanol < 3000ppm |
ND |
Ethanol < 5000ppm |
86ppm |
|
Ethyl acetate < 5000ppm |
ND |
|
Propyl bromide < 150ppm |
ND |
|
Dimethyl sulfoxide < 5000ppm |
ND |
|
Dimethyl Sulfate |
<150ppm |
ND |
Assay |
98.5%-101.0%(dried substance) |
99.7% |
Microbiological Examination |
TAMC < 1000cfu/g |
<10 cfu/g |
TYMC < 100cfu.g |
<10 cfu/g |
|
Escherichia Coli: Not detected in 1g |
ND |
|
Conclusion |
The sample complies with the Specifications. |
Usage |
Promestriene is a type of anti-estrogen drug and a local estrogen supplement. It is mainly used clinically for atrophic lesions of the vulva, vestibule, and vaginal ring caused by estrogen deficiency. It acts locally on the vaginal mucosa, thickening the mucosa, balancing vaginal pH, improving the vaginal environment, and enhancing the resistance of vaginal tissues. It can effectively prevent and treat atrophic vaginitis and has a strict local estrogen effect.
Advantages of Promestriene API in China
1. Clinical Experience and Efficacy:
Promestriene has been clinically used in over 40 countries for more than 40 years and has been proven to be safe and effective. It has been widely used in the treatment of vaginal infections and atrophic vaginitis, with good patient tolerance.
2. Combination Therapy:
Promestriene can be used in combination with other drugs to enhance therapeutic efficacy.
For example, it can be combined with recombinant human interferon α-2b vaginal effervescent capsules or lactobacillus live bacteria preparations to treat atrophic vaginitis, achieving high cure rates and low recurrence rates.
3. Safety and Low Side Effects:
Promestriene is a local drug that is not absorbed by the vaginal mucosa and does not have systemic estrogen effects on organs away from the vagina.
Therefore, it can effectively avoid the systemic risks associated with long-term local estrogen supplementation via the vagina. The adverse reactions are relatively few and mild, with high safety.
4. Regulatory Approval and Market Availability:
Promestriene products have been approved by relevant regulatory authorities and are available on the market. This ensures the quality and safety of the drugs used in clinical practice.
*Products under the patent are only for R&D use