Product name: Glutathione Injection
Contains: 600mg
Characteristics:
--Highly safe: It is an endogenous substance existing in human body.
--Proven efficacy: In clinical use for decades in many countries, including Japan, Italy, etc.
--Widely used in liver protection as well as cancer therapy adjunct.
Dosage form:
Lyophilized powder for injection
Indications:
--Chronic hepatitis;
--Chemotherapy patients;
--Radiotherapy patients;
--Detoxification for drug toxicity.
Storage Situation: Stored in a cool and dry well-closed container. Keep away from moisture and strong light/heat.
| SPECIFICATION |
ACCEPTANCE CRITERIA |
RESULT |
| APPEARANCE |
WHITE CRYSTALLINE POWDER |
WHITE CRYTALLINE POWDER |
| IDENTIFICATION |
PASS TEST |
PASS TEST |
| STATE OF SOLUTION(T%) |
NOT LESS THAN 98.0% |
NOT LESS THAN 98.0% |
| SPECIFIC ROTATION (AT 20ºC) |
-17.5 to -15.5ºC |
-16.3ºC |
| AMMONIUM(NH4) |
NOT MORE THAN 0.020% |
NOT MORE THAN 0.020% |
| SULFATE(S04) |
NOT MORE THAN 0.048% |
NOT MORE THAN 0.048% |
| IRON(Fe) |
NOT MORE THAN 10 ppm |
NOT MORE THAN 10 ppm |
| HEAVY METALS(pb) |
NOT MORE THAN 10ppm |
NOT MORE THAN 10ppm |
| ARSENIC(As203) |
NOT MORE THAN 1ppm |
NOT MORE THAN 1ppm |
| RELATED SUBSTANCES(HPLC) |
NOT MORE THAN 2.0% |
NOT MORE THAN 2.0% |
| LOSS ON DRYING |
NOT MORE THAN 0.50% |
0.15% |
| RESIDUE ON IGNITION |
NOT MORE THAN 0.10% |
0.02% |
| ENDOTOXIN |
LESS THAN 6.0 EU/g |
LESS THAN 6.0 EU/g |
| ASSAY(DRY BASIS) |
98.0 to 101.0% |
99.3% |
Audited Supplier 
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