Customization: | Available |
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Application: | Injection |
Usage Mode: | IV |
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Glutathione is an antioxidant produced in cells. It's comprised largely of three amino acids: glutamine, glycine, and cysteine.
Product Name | Glutathione for Injection | ||||
Batch No. | Sample | Specification | 600mg/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. |