Menotrophin
CAS No.: 9002-68-0 (Gonadotrophin; Treatment of infertility)

Short Description:

Source: Extracted from the urine of menopausal 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.

Menotrophin-Pharmacopoeia?Standard:?BP


Product Detail

Product Tags

CAS No.:?9002-68-0
Complies with CP2020,, BP2023

Specification

Menotrophin

Source

Menopausal woman urine

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.

Pharnacopoeia standard

CP

BP

Character

An almost white to slightly yellow powder.

Soluble in water.

An almost white or slightly yellow powder.

Soluble in water

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%

_________

Water

Not more than 5.0%

Not more than 5.0%

Abnormal toxicity

All the animals survive for 48 hours.

_________

Bacterial endotoxin

Not more than 1.0EU per IU FSH.

Not more than 0.78 EU per IU FSH.

Potency

FSH

Not less than 400IU/mg

Not less than 40 IU/mg

LH/FSH

Approximately 1

Approximately 1

Microbial limit

TAMC

≤103 CFU/g

_________

TYMC

≤102 CFU/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 not exceeding 10°C.

Kept in an airtight, tamper-evident container and protected from light.

Category

Gonadotropin drugs

Preparation

Menotrophin for injection

Indications

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.


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