| Menotrophin | |||
| Source | Menopausal woman urine | ||
| Process description | Menotrophin obtained from the urine of post-menopausal women, mainly contain follicle-stimulating hormone and luteinizing hormone. | ||
| Manufacturing requirements | 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. | ||
|
Pharnacopoeia standard |
CP |
BP |
|
|
Character |
An almost white to slightly yellow powder.Soluble in water. | An almost white or slightly yellow powder.Soluble in water | |
|
Identification |
Causes enlargement of the ovaries of immature female rats and increases the weight of the seminal vesicles and prostate gland of immature male rats when administered as directed in the Assay. | Causes enlargement of the ovaries of immature female rats and increases the weight of the seminal vesicles and prostate gland of immature male rats when administered as directed in the Assay. | |
|
Test |
ResidualSolvent(ethanol) | ≤0.5% | ≤0.5% |
| Water | ≤5% | Not more than 5.0% | |
| Abnormal toxicity | Conform with regulation | Conform with regulation | |
| Bacterial endotoxin | ≤1EU/unit | Not more than 0.78 IU per IU of FSH. | |
|
Potency |
FSH | Not less than 400IU/mg | Not less than 40 IU/mg |
| LH/FSH | Approximately 1 | Approximately 1 | |
|
Microbial limit |
TAMC | ≤103 CFU/g | ≤103 CFU/g |
| TYMC | ≤102 CFU/g | ≤102 CFU/g | |
|
Virus |
Hbs Ag | Should be negative（10mg/ml） | Should be negative（10mg/ml） |
| HCV antibodies | _________ | Should be negative | |
| HIV I+II | _________ | Should be negative | |
|
Storage |
Kept in an airtight, tamper-evident container and protected from light. Preserved in cold place. | Menotrophin should be kept in an airtight, tamper-evident container and protected from light. | |
|
Category |
Gonadotropin drugs | ||
|
Preparation |
Menotrophin for injection | ||