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| Test | Specification | |
|---|---|---|
| Min | Max | |
| ASSAY (ANHYDROUS BASIS) | 97 | 103.00% |
| SPECIFIC ROTATION | -5� to -6� | -5� to -6� |
| WATER DETERMINATION | 11.00% | |
| ORGANIC IMPURITIES, PROCEDURE 2 | . | . |
| LIOTHYRONINE | 1.00% | |
| MONOCHLOROTRIIODOTHYRONINE | 0.15% | |
| LEVOTHYROXINE N-METHYLAMIDE | 0.15% | |
| TRIIODOTHYROACETIC ACID, OR T3-ACETIC ACID | 0.15% | |
| O-(4-HYDROXY-3,5-DIIODOPHENYL)THYROXINE, OR T6 | 0.50% | |
| O-METHYL-TETRAIODOTHYROETHYLAMINE, OR T4-AMINE O-METHYL | 0.30% | |
| T4-ACETIC ACID | 0.30% | |
| INDIVIDUAL UNSPECIFIED IMPURITY | 0.10% | |
| TOTAL IMPURITIES | 2.00% | |
| ELEMENTAL IMPURITIES: | ||
| COPPER (Cu) | AS REPORTED | AS REPORTED |
| IDENTIFICATION (A) | SPECTRUM | SPECTRUM |
| IDENTIFICATION (B) | RETENTION | RETENTION |
| EXPIRATION DATE | ||
| DATE OF MANUFACTURE | ||
| APPEARANCE | ||
| RESIDUAL SOLVENTS | AS REPORTED | AS REPORTED |
