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| Test | Specification | |
|---|---|---|
| Min | Max | |
| ASSAY (ANHYDROUS BASIS) | 98.5 | 102.00% |
| SPECIFIC ROTATION | -24??to -26??/td> | -24??to -26??/td> |
| pH (1 in 20 solution) | 4 | 5.5 |
| WATER DETERMINATION | 13.00% | |
| RESIDUE ON IGNITION | 0.10% | |
| ORGANIC IMPURITIES: | ||
| TROPIC ACID | 0.20% | |
| NORSCOPOLAMINE | 0.50% | |
| HYOSCYAMINE | 0.20% | |
| APOHYOSCINE | 0.20% | |
| APOATROPINE | 0.20% | |
| ANY OTHER INDIVIDUAL IMPURITY | 0.10% | |
| TOTAL IMPURITIES | TO PASS TEST | TO PASS TEST |
| ELEMENTAL IMPURITIES | AS REPORTED | |
| IDENTIFICATION | TO PASS TEST | |
| EXPIRATION DATE | ||
| DATE OF MANUFACTURE | ||
| APPEARANCE | ||
| RESIDUAL SOLVENTS | TO PASS TEST | |
