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  • 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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