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

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.

Menotrophin-Pharmacopoeia Standard: BP


Product Detail

Product Tags

CAS No.: 61489-71-2
Complies with CP2020, USP43, BP2022

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

ResidualSolvent(ethanol) ≤0.5% ≤0.5%
Water ≤5% Not more than 5.0%
Abnormal toxicity Conform with regulation Conform with regulation
Bacterial endotoxin ≤1EU/unit Not more than 0.78 IU per IU of 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 ≤103 CFU/g
TYMC ≤102 CFU/g ≤102 CFU/g

Virus

Hbs Ag Should be negative(10mg/ml) Should be negative(10mg/ml)
HCV antibodies _________ Should be negative
HIV I+II _________ Should be negative

Storage

Kept in an airtight, tamper-evident container and protected from light. Preserved in cold place. Menotrophin should be kept in an airtight, tamper-evident container and protected from light.

Category

Gonadotropin drugs

Preparation

Menotrophin for injection

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