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| Test | Specification | |
|---|---|---|
| Min | Max | |
| ASSAY (ANHYDROUS BASIS) | 98 | 102.00% |
| WATER DETERMINATION | 5 | 8.00% |
| ELEMENTAL IMPURITIES | AS REPORTED | AS REPORTED |
| ORGANIC IMPURITIES TEST 2: | ||
| PANTOPRAZOLE RELATED COMPOUND C | 0.10% | |
| PANTOPRAZOLE RELATED COMPOUND A | 0.20% | |
| PANTOPRAZOLE RELATED COMPOUND D & E | 0.20% | |
| PANTOPRAZOLE RELATED COMPOUND E | 0.10% | |
| PANTOPRAZOLE RELATED COMPOUND B | 0.15% | |
| ANY OTHER INDIVIDUAL IMPURITY | 0.10% | |
| TOTAL IMPURITIES | 0.50% | |
| IDENTIFICATION | TO PASS TEST | TO PASS TEST |
| EXPIRATION DATE | ||
| DATE OF MANUFACTURE | ||
| APPEARANCE | ||
| RESIDUAL SOLVENTS | TO PASS TEST | TO PASS TEST |
