CAS No.: 9002-61-3
Complies with CP2020, BP2023, EP11.0
Chorionic Gonadotrophin |
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Source |
Pregnant woman urine |
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Process description |
Chorionic gonadotrophin is a dry preparation of placental glycoproteins which have luteinising activity. It is extracted from the urine of pregnant women. | ||
Production 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. | ||
Pharmacopoeia standard |
CP |
EP/BP |
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Character |
White or yellowish-White, amorphous powder. Soluble in water and insoluble in ethanol, acetone or ether. |
White or yellowish-white, amorphous powder. Soluble in water. |
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Identification |
According to the method under the potency determination item, the results should be able to increase the uterine weight of immature female mice |
When administered to immature rats as prescribed in the assay, it causes an increase in the mass of the seminal vesicles and of the prostate gland. |
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Test |
Residual solvent |
Not more than 0.5% |
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Water |
Not more than 5.0% |
Not more than 5.0% |
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Estrogen |
Should not be positive |
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Abnormal toxicity |
All the animals survive for 48 hours. |
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Bacterial endotoxin |
Less than 0.01EU per IU of HCG |
Less than 0.02 IU per IU of HCG |
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Potency |
Chorionic gonadotrophin bioassay |
Not less than 4500 IU/mg |
Not less than 2500 IU/mg |
Microbial limit |
TAMC |
≤103CFU/g |
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TYMC |
≤102CFU/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 of 2 °C to 10°C. |
In an airtight container, protected from light, at a temperature of 2 °C to 8 °C. |
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Category |
Gonadotropin drugs |
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Preparation |
Chorionic Gonadotrophin for injection |
1、Diagnosis and treatment of prepubertal cryptorchidism
2、Male infertility caused by hypopituitarism can be combined with urogonadotropin. Patients with chronic hypogonadotropin function should also be supplemented with testosterone therapy.
3、Anovulatory infertility in women caused by hypopituitaristic gonadotropin function is often combined with urogonadotropin to promote ovulation after clomiphene treatment is ineffective.
4、Used for in vitro fertilization to obtain multiple oocytes in combination with menotrophin.
5、Treatment of luteal insufficiency in women
6、Functional uterine bleeding, threatened abortion in the first trimester, recurrent miscarriage.