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| Test | Specification | |
|---|---|---|
| Min | Max | |
| ASSAY (DRIED BASIS) | 98 | 102.00% |
| OPTICAL ROTATION | -0.10??to +0.10 | -0.10??to +0.10 |
| LOSS ON DRYING | 0.50% | |
| RESIDUE ON IGNITION | 0.20% | |
| ORGANIC IMPURITIES | ACCEPTANCE CRI | |
| DESCHLOROBENZYL ECONAZOLE | 0.25% | |
| MICONAZOLE QUARTERNARY SALT | 0.25% | |
| MICONAZOLE BENZYL ANALOG | 0.25% | |
| MICONAZOLE RELATED COMPOUND C | 0.25% | |
| MICONAZOLE RELATED COMPOUND I | 0.05% | |
| ECONAZOLE NITRATE | 0.25% | |
| MICONAZOLE 2,6 ISOMER | 0.25% | |
| MICONAZOLE 2,5 ISOMER | 0.25% | |
| MICONAZOLE RELATED COMPOUND F | 0.25% | |
| ANY INDIVIDUAL, UNSPECIFIED IMPURITY | 0.10% | |
| TOTAL IMPURITIES | 0.50% | |
| ELEMENTAL IMPURITIES | AS REPORTED | |
| IDENTIFICATION | TO PASS TEST | |
| EXPIRATION DATE | ||
| DATE OF MANUFACTURE | ||
| APPEARANCE | ||
| RESIDUAL SOLVENTS | TO PASS TEST | |
