CAS No.: 9002-68-0
Complies with CP2020,, BP2023
Menotrophin | |||
Source |
Menopausal woman urine |
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Process description |
Menotrophin obtained from the urine of post-menopausal women, mainly contain follicle-stimulating hormone and luteinizing hormone. | ||
Manufacturing requirements |
This product should be extracted from healthy human urine. The production process should conform with the requirements of current version of Good Manufacturing Practice. It needs to undergo appropriate technological methods for virus safety control during the production process, so that any viruses such as hepatitis virus, human immunodeficiency virus, etc. can be removed or inactivated. |
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Pharnacopoeia standard |
CP |
BP |
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Character |
An almost white to slightly yellow powder. Soluble in water. |
An almost white or slightly yellow powder. Soluble in water |
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Identification |
Causes enlargement of the ovaries of immature female rats and increases the weight of the seminal vesicles and prostate gland of immature male rats when administered as directed in the Assay. | Causes enlargement of the ovaries of immature female rats and increases the weight of the seminal vesicles and prostate gland of immature male rats when administered as directed in the Assay. | |
Test |
Residual Solvent(ethanol) |
Not more than 0.5% |
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Water |
Not more than 5.0% |
Not more than 5.0% |
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Abnormal toxicity |
All the animals survive for 48 hours. |
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Bacterial endotoxin |
Not more than 1.0EU per IU FSH. |
Not more than 0.78 EU per IU FSH. |
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Potency |
FSH |
Not less than 400IU/mg |
Not less than 40 IU/mg |
LH/FSH |
Approximately 1 |
Approximately 1 |
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Microbial limit |
TAMC |
≤103 CFU/g |
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TYMC |
≤102 CFU/g |
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Escherichia coli |
Should not be detected |
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Virus |
Hbs Ag |
Should be negative |
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Storage |
Store in an airtight container, protected from light, at a temperature not exceeding 10°C. |
Kept in an airtight, tamper-evident container and protected from light. |
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Category |
Gonadotropin drugs |
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Preparation |
Menotrophin for injection |
1.Use in combination with chorionic gonadotropin or clomiphene to treat anovulatory infertility. It can be used in anovulatory patients with insufficient pituitary gonadotropin secretion or hypothalamic gonadotropin-releasing hormone secretion, and is currently generally advocated for cases where ovulation induction is ineffective, such as clomiphene or bromocriptine. Combined with clomiphene, it can reduce the dosage of this product by about 50%, and at the same time can reduce the incidence of ovarian hyperstimulation.
2.It is also used for primary or secondary amenorrhea, male sperm deficiency and ovarian function tests.