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CAS number： 768-94-5
Molecular formula：
molecular weight：
Chemical structure：
| PRDDUCT NAME | AMANTADINE HCL |
|
| SHELF LIFE | 3 YEARS |
|
| TEST ITEM | SPECIFICATION LIMITS | TEST RESULT |
| APPEARANCE | WHITE CRYSTALLINE POWDER | WHITE CRYSTALLINE POWDER |
| IDENTIFICATION | IR: MEETS THE REQUIREMENTS | IR: MEETS THE REQUIREMENTS |
| CA: POSITIVE REACTION | CA: POSITIVE REACTION | |
| ACIDITY (PH) | 3.0-5.0 | 3.94 |
| ASSAY | 99.0-101.0% | 100.1% |
| LOSS ON DRYING | NOT MORE THAN 0.5% | 0.07% |
| RESIDUAL ON IGNITION | NOT MORE THAN 0.1% | 0.03% |
| HEAVY METALS | NOT MORE THAN 0.0050% | ＜0.0005% |
| RESIDUAL SOLVENT (ACETONE) | NOT MORE THAN 0.5% | 0.0151% |
| RELATED SUBSTANCE | UNKNOWN IMPURITY ≤0.1% | 0.08% |
| 2-AMANTADINE HCL ≤0.3% | 0.03% | |
| TOTAL IMPURITY≤1.0% | 0.11% | |
| CLARITY OF SOLUTION | CLEAR | CLEAR |
| COLOUR OF SOLUTION | COLOURLESS | COLOURLESS |
| CONCLUSION: | CONFIRMED WITH USP38， BO2012，EP7.5 |
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