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

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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.

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

Next: Chorionic Gonadotrophin
CAS No.: 9002-61-3 (Gonadotrophic hormone)

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