Audited Supplier
300mg/5ml vial; 300mg/7ml vial; 300mg/10ml vial
Injection
IV
Adult
Solid
Powder
Biological Products
Chemical Synthesis
C10h17n3o6s
307.32300
182-192 Degree
410.1 Degrees
White Lyophilized Powder
Without
Carton
300mg/5ml vial 300mg/7ml vial 300mg/10ml vial
China
3004909099
Product Description
Indication
It is used for the prevention and treatment of tissue and cell damage caused by drugs (such as chemotherapy drugs, antituberculosis drugs, psychiatric drugs, paracetamol, etc.), radiotherapy, alcohol, organic phosphorus, etc.
It has a protective effect on liver damage caused by various reasons.
Usage and dosage
This product can be intramuscularly injected, or slowly intravenously injected, or added to the infusion intravenous drip, or according to the doctor's order 1-2 per day.
Certificate of Analysis
| Product Name | Glutathione for Injection | ||||
| Batch No. | Sample | Specification | 300mg/7ml | ||
| Number | Without | Quantity | 300vials | ||
| Test items | Quality Standard | Test Result | |||
| Characteristics | White lyophilized powder | Complies | |||
| Identification | |||||
| Identification by HPLC | The retention time of the main peak of the test solution should be the same as that of the reduced glutathione control solution | Complies | |||
| Sodium salt identification | Should be positive | Positive | |||
| Inspect | |||||
| PH | PH should be 4.8~7.0 | 5.2 | |||
| Loss on drying | Should not be exceed 6.0% | 5.2% | |||
| Dissolution time limit | Should be completely dissolved within one minute. | Complies | |||
| Related substances | The sum of various impurities shall not exceed 5.0% . | 2.1% | |||
| Bacterial endotoxin | Should be less than 0.4EU for each 1mg endotoxin | Complies | |||
| Content Uniformity | Should be meet requirement | Complies | |||
| Visible Particles | Should be meet requirement | Complies | |||
| Insoluble particles | Should be meet requirement | Complies | |||
| Sterile | Should be meet requirement | Complies | |||
| Assay | It should be contains glutathione(C10H17N3O6S) 95.0%~104.0% of labeled amount. | 96.3% | |||
| Conclusions:The product complies with the requirement of CP standard. | |||||
