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 or

virtually 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.

Soluble in water.

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

Maximum 5.0 per cent

Residual solvent

Not more than 0.5%

_______

Bacterial endotoxins

Less than 0.01EU per IU of FSH

Less than 0.40EU per IU of FSH

PH

5.5-7.0

_______

Appearance of solution

The solution is clear and colorless

_______

Abnormal endotoxin

All the animals survive for 48 hours.

_______

potency

FSH

Not less than 200IU/mg

Not less than 90IU/mg

Specific activity

More than 8500IU/mg.pr

_______

Residual luteinising activity

LH/FSH should be N.M.T 1/60

LH/FSH should be N.M.T 1/60

Microbial limit

TAMC

≤102cfu/750IU

_______

TYMC

≤101cfu/750IU

_______

Escherichia coli

Should not be detected

_______
Virus

Hbs Ag

Should be negative

_______

HCV antibodies

Should be negative

_______

HIV I+II

Should be negative

_______

Storage

In an airtight container, protected from light, at a temperature of 2 °C to 8 °C.

In an airtight container, protected from light, at a temperature of 2 °C to 8 °C.

Category

Gonadotropins

Preparation

Urofollitropin for injection

Indications

1. It is mainly used in combination with chorionic gonadotropin for anovulatory infertility caused by insufficient gonadotropin secretion (hypothalamic pituitary dysfunction or disharmony). It is generally recommended to be used in cases of ineffective ovulation induction such as clomiphene (CC) or bromocriptine.

2. Combined with chorionic gonadotropin, it is used for the treatment of primary or secondary amenorrhea and ovarian function test.

3. It is used for polycystic ovary syndrome (PCOS), especially for those who are ineffective with clomiphene.

4. In the assisted pregnancy technology, the stimulation of superovulation in normal ovulating women is often used in combination with clomiphene and chorionic gonadotropin to obtain multiple eggs at a time.

5. Combined with chorionic gonadotropin to treat male hypogonadism and infertility, and stimulate spermatogenic function.


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