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| Test | Specification | |
|---|---|---|
| Min | Max | |
| ASSAY (USP) | 98 | 102.00% |
| ASSAY (JP) | 99.00% | |
| MELTING POINT (JP) | 132.5 | 134.5�C |
| RESIDUE ON IGNITION | 0.10% | |
| ALCOHOL-INSOLUBLE MATTER | 0.04% | |
| CHLORIDE | 0.01% | |
| SULFATE | 0.01% | |
| ELEMENTAL IMPURITIES | AS REPORTED | AS REPORTED |
| HEAVY METALS (JP) | 20 ppm | |
| ORGANIC IMPURITIES: | ||
| UREA RELATED COMPOUND A | 0.10% | |
| INDIVIDUAL IMPURITY | 0.10% | |
| TOTAL IMPURITIES | 2.00% | |
| IDENTIFICATION (A) | SPECTRUM | SPECTRUM |
| IDENTIFICATION (B) | RETENTION | RETENTION |
| IDENTIFICATION (C) | RED PURPLE | RED PURPLE |
| IDENTIFICATION (D) | WHITE | WHITE |
| EXPIRATION DATE | ||
| DATE OF MANUFACTURE | ||
| APPEARANCE | ||
| RESIDUAL SOLVENTS | AS REPORTED | |
