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        Urofollitropin
        CAS No.: 97048-13-0 (Follicle-stimulating hormone)

        Short Description:

        Source: Extracted from the urine of menopausal women
        Function and use: Stimulate the proliferation and differentiation of granulosa cells, induce the synthesis of granulosa cell receptors, and bind to the receptors, activate the activity of enzymes in the body, promote the transformation between hormones, regulate the growth and development of human organs, sexual maturation and reproductive activities A series of related physiological processes. Regulates the menstrual cycle of women to promote follicular development and ovulation in women, regulates testicular function and gonadotropin secretion in men, and treats male infertility; it is clinically used for in vitro reproductive assistance.

        Urofollitropin-Pharmacopoeia?Standard:?BP/EP


        Product Detail

        Product Tags

        Specification

        Urofollitropin
        Source urine of menopausal women

        Standard

        NMPA

        BP/EP

        Definition

        This product is the gonadotropin extracted from the urine of postmenopausal women, which is freeze-dried with lactose as excipient.?It mainly contains follicle stimulating hormone (FSH), and almost does not contain luteinizing hormone (LH). Dried preparation containing menopausal gonadotrophin obtained from the urine of post-menopausal women. It has follicle-stimulating activity and no orvirtually no luteinising activity.

        Production

        It is prepared by suitable collection and extraction procedures followed by purification steps. The method of preparation includes steps that have been shown to remove and/or inactivate extraneous agents. In addition, the process is designed to minimise microbial contamination.

        Character

        White or almost white powder Almost white or slightly yellowish powder.Soluble in water.

        Identification

        When administered to immature female rats as prescribed in the assay, it causes significantly enlargement?of the ovaries of young female rats When administered to immature female rats as prescribed in the assay, it causes enlargement of the ovaries.

        Test

        Water _______ Maximum 5.0 per cent
        Bacterial endotoxins ≤0.01EU?per IU of FSH Less than 0.40IU per IU of FSH
        PH 5.5-7.0 _______
        Appearance of solution Should be clear. _______
        Residual luteinizing hormone The average value of the reaction caused by each dose of the tests?should be lower than the average value of the reaction caused by the corresponding dose of the standards The mean ascorbic acid content of the ovaries of the rats treated with the preparation to be examined is not significantly lower than that of the rats treated with the middle dose of the reference preparation (calculated from the regression equation) at the 0.05 significance level.
        Related substances The impurity spot of the test solution shall not be deeper than the main spot of the control solution (5.0%). _______
        Loss on drying Not more than 5.0% _______
        Abnormal endotoxin Conform with regulation _______
        potency FSH Not less than 200IU/mg Not less than 90IU/mg
        Specific activity More than 8500IU/mg.pr _______
        FSH/LH More than 100:1 Maximum 60/1
        Microbial limit TAMC ≤102cfu/750IU ≤102cfu/750IU
        TYMC ≤101cfu/750IU ≤101cfu/750IU
        Escherichia coli Should not be detected Should not be detected(750IU)
        Virus Hbs Ag Should be negative Should be negative
        HCV antibodies Should be negative Should be negative
        HIV I+II Should be negative Should be negative

        Storage

        Protected?from light, seal, and store in a cold place In an airtight container, protected from light, at a temperature of 2 °C to 8 °C.

        Category

        Gonadotropins

        Preparation

        Urofollitropin for injection

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