Chorionic Gonadotrophin
CAS No.: 9002-61-3 (Gonadotrophic hormone)

Short Description:

Source: Extracted from the urine of healthy pregnant women
Function and use: For women, it can promote the maturation and ovulation of follicles, and maintain the function of the corpus luteum. For men, it can stimulate the development of Leydig cells, increase androgen secretion, promote testicular descent and the development of male secondary sexual characteristics. Combined with urinary gonadotropin, it can simulate the physiological peak of luteinizing hormone and induce ovulation. Clinically, chorionic gonadotropin is still the drug of choice for the treatment of menstrual disorders, anovulatory infertility, threatened abortion and habitual live birth, cryptorchidism, and male sexual dysfunction.

Chorionic?Gonadotrophin-Pharmacopoeia?Standard:?BP/EP


Product Detail

Product Tags

CAS No.: 9002-61-3
Complies with CP2020, BP2023, EP11.0

Specification

Chorionic Gonadotrophin

Source

Pregnant woman urine

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

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.

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.

Test

Residual solvent

Not more than 0.5%

_________

Water

Not more than 5.0%

Not more than 5.0%

Estrogen

Should not be positive

_________

Abnormal toxicity

All the animals survive for 48 hours.

_________

Bacterial endotoxin

Less than 0.01EU per IU of HCG

Less than 0.02 IU per IU of HCG

Potency

Chorionic gonadotrophin bioassay

Not less than 4500 IU/mg

Not less than 2500 IU/mg

Microbial limit

TAMC

≤103CFU/g

_________

TYMC

≤102CFU/g

_________

Escherichia coli

Should not be detected

_________

Virus

Hbs Ag

Should be negative

_________

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.

Category

Gonadotropin drugs

Preparation

Chorionic Gonadotrophin for injection

Indications

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.


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