| Solubility | H2O: 50mg/mL, soluble |
| Appearance | white powder |
| Merck | 13,4249 |
| Storage Condition | 2-8°C |
| Use | Renal stimulating hormone drugs for the treatment of anovulatory infertility |
| Safety Description | S22 - Do not breathe dust. S24/25 - Avoid contact with skin and eyes. |
| WGK Germany | 3 |
| RTECS | LP6330000 |
| FLUKA BRAND F CODES | 10-21 |
This product is a gonadotropin extracted from the urine of postmenopausal women, which mainly contains Follicle-stimulating Hormone (FSH) and luteinizing Hormone (LH). The titer of follicle stimulating hormone in each lmg should not be less than 400 units, and the ratio of the titer of luteinizing hormone to the titer of follicle stimulating hormone is about 1.
This product should be extracted from the urine of healthy people, and the production process should comply with the requirements of the current version of "good manufacturing practice. This product in the production process need to be appropriate processing methods, in order to make any Virus such as hepatitis Virus, human immunodeficiency Virus, such as removal or inactivation.
According to the method under the item of potency measurement, the measurement results should be able to enlarge the ovaries of the minor female rats and increase the weight of the seminal vesicles and prostate glands of the minor male rats.
take this product about O.lg, precision weighing, in the top empty bottle, Precision Add 2ml of water to dissolve, seal, as a test solution; Another appropriate amount of anhydrous ethanol, precision weighing, A solution containing 0.25mg per 1 ml was prepared by dilution with water, and 2ml was precisely weighed into a headspace bottle and sealed as a reference solution. According to the determination method of residual solvent (General 0861 second method), polyethylene glycol is used as the stationary liquid; The initial temperature is 60°C, the maintenance time is 5 minutes, and the temperature is raised to 200°C at the rate of 50°C per minute for 15 minutes; the inlet temperature was 200°C; The detector temperature was 250°C; The headspace bottle equilibrium temperature was 90°C and the equilibrium time was 20 minutes. The reference solution and the test solution were injected in Headspace respectively, and the chromatogram was recorded. According to the external standard method to calculate the peak area, the residual amount of ethanol should comply with the provisions.
take this product, according to the moisture determination method (0832 first method), the water content shall not exceed 5.0%.
take this product, add 0.9% sodium chloride solution to dissolve and dilute the solution containing lOmg per lml, according to the kit instructions, should be negative.
This product is dissolved and diluted with sodium chloride injection to make a solution containing 100 units (based on follicle stimulating hormone titer) per 1 ml, which is checked according to law (General rule 1141), according to intravenous administration, should comply with the provisions.
take this product and check it according to law (General rule 1143). The amount of endotoxin contained in 1 unit of urotropin (based on follicle-stimulating hormone titer) should be less than 1.0EU.
as determined by follicle stimulating hormone bioassay (General rule 1216), it should meet the regulations, and the result of the determination should be 80% to 125% of the nominal value.
as determined by the luteinizing hormone bioassay (General rule 1217), it shall be as specified and the result of the determination shall be 80% to 125% of the nominal value.
gonadotropins.
shading, sealing, storage in cold place.
This product is white or off-white lyophilized cake or powder.
take this product, according to the identification test under the item of urine promoting hormone, show the same results.
take this product 5 (150 units) or 10 (75 units), according to the method of urine promoting hormone determination.
The same as the urine promoting hormone.
in terms of follicle stimulating hormone titer (1) 75 units (2)150 units
shade, close, and store in a cool place.
| EPA chemical substance information | information provided by: iaspub.epa.gov (external link) |
| action | follicle stimulating hormone (Follicle-stimulatinghormone, follicle stimulating hormone) is a kind of animal anterior pituitary gland secretion of glycoprotein gonadotropin. With the regulation of the body's growth, sexual maturation and reproduction. follicle stimulating hormone can promote endometrial growth, ovulation and stimulate the development of multiple follicles in female animals. There is a specific receptor of follicle stimulating hormone on the target cell. After the follicle stimulating hormone receptor on the cell membrane is combined with the follicle stimulating hormone receptor, the adenylate cyclase is activated by G protein coupling mechanism, the intracellular cAMP is increased or calcium ion influx is caused, thereby affecting the metabolic or functional activity of the cell. |
| Use | follicle-stimulating hormone is a kind of gonadotropin injectable protein drugs, it is mainly used for the treatment of female and male patients with infertility and reproductive disorders. Renal stimulating hormone drugs for the treatment of anovulatory infertility |
| toxic substance data | information provided by: pubchem.ncbi.nlm.nih.gov (external link) |