| PRODUCT NAME： | AMPICILLIN TRIHYDRATE | |
| SHELF LIFE: | 3 YEARS | |
| ITEMS | SPECIFICATION | RESULTS |
| APPEARANCE | A WHITE OR ALMOST WHITE CRYSTALLINE POWDER | A WHITE CRYSTALLINE POWDER |
| INFRARED ABSORPTION SPECTRUM | A: INFRARED ABSORPTION SPECTRUM ACCORD WITH THE REFERENCE SPECTRUM OF AMPICILLIN TRIHYDRATE | MEETS THE REQUIREMENTS |
| PH | 3.5-5.5 | 4.8 |
| SPECIFIC OPTICAL ROTATION | +280゜ – +305゜ | +298゜ |
| RELATED SUBSTANCE | ANY IMPURITY≤1.0% | ANY IMPURITY: 0.34% |
| DIMETHYLANILINE | ≤20PPM | NEVER USED IN THE PRODUCTION |
| WATER | 12.0%-15.0% | 13.6% |
| SULPHATED ASH | SULPHATED ASH | 0.1% |
| ASSAY |
AMPICILLIN TRIHYDRATE CONTAINS NOT LESS THAN 96.0% AND NOT MORE THAN 102.0% OF C16H19N3O4S,CALCULATE WITH REFERENCE TO THE ANHYDROUS SUBSTANCE |
99.6% |
| REMARKS: BULK DENSITY: 0.63G/ML; TAPPED DENSITY: 0.90G/ML; PARTICLE SIZE(20-80MESH): 74% | ||
| CONCLUSION | THE ABOVE PRODUCT CONFORMS TO BP2012 | |