CAS No.: 9002-61-3
Complies with CP2020, USP43, BP2022, EP10.0
Chorionic Gonadotrophin | |||
Source | Pregnant woman?urine | ||
Process description | Chorionic gonadotrophin is a dry preparation of placental glycoproteins?which have luteinising activity. It is extracted from the urine of pregnant women. | ||
Productionrequirements | This product should be extracted from healthy human urine. The production process should conform with the requirements of current?version of?Good Manufacturing Practice. It needs to undergo appropriate technological methods for virus safety control during the production process, so that any viruses such as hepatitis virus, human immunodeficiency virus, etc. can be removed or inactivated. | ||
Pharmacopoeia standard |
CP |
EP/BP |
|
Character |
White or yellowish-White, amorphous powder.?Soluble?in water and insoluble in ethanol, acetone or ether. | White or yellowish-white, amorphous powder.?Soluble in water. | |
Identification |
When administered to immature rats as prescribed in the assay, it causes an increase in the mass of the seminal vesicles and of the prostate gland. | When administered to immature rats as prescribed in the assay, it causes an increase in the mass of the seminal vesicles and of the prostate gland. | |
Test |
Residual solvent | Conform with regulation | _________ |
Water | ≤5% | maximum 5.0 per cent. | |
Estrogen | Should not be positive | _________ | |
Abnormal toxicity | Conform with regulation | _________ | |
Bacterial endotoxin | ≤0.01EU?per IU of HCG | Less than 0.02 IU per IU of HCG | |
Potency |
Chorionic gonadotrophin bioassay | Not less than 4500 IU/mg | Not?less than 2500 IU/mg |
Microbial limit |
TAMC | ||
TYMC | |||
Virus |
Hbs Ag | Should be negative(10mg/ml) | _________ |
HCV antibodies | _________ | ||
HIV I+II | _________ | ||
Storage |
In an airtight, tamper-proof container, protected from light. Preserved at cold place. | In an airtight, tamper-proof container, protected from light at a temperature of 2 °C to 8 °C. | |
Category |
Gonadotropin drugs | ||
Preparation |
Chorionic Gonadotrophin for injection |