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 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