Customization: | Available |
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Powder: | Yes |
Customized: | Non-Customized |
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Test items | Limit | Results | |||
Characteristics | White, hard particles ,hygroscopic. Freely soluble in water, soluble in alcohol. | Conform | |||
Appearance of Solution | The solution is clear | Conform | |||
Solution color | The colour of the solution obtained in the test aspect of the solution does not exceed that of the reference solution | Conform | |||
ldentification | Positive | Positive | |||
pH | 4.5-9.2 | 6.3 | |||
Appearance of Solution | Conform | Conform | |||
Limit of magnesium and alkali salts | Not more than 1.0% | 0.2% | |||
lron, aluminum. and phosphate | Conform | Conform | |||
Aluminum | Not more than 0.0001% | Conform | |||
Heavy Metals | Not more than 0.001% | Conform | |||
Bacterial endotoxins | Not more than5 IU/g | Conform | |||
Mierobial limit | Not more than500cfu/gl | Conform | |||
Organic Volatile impurities | Meet the requiryment | Conform | |||
Barium | After 15 min the solution does not show opalescence | Conform | |||
Assay | 99.0%-107.0% | 99.5% | |||
Decision : Complies With the USP41 |