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| Test | Specification | |
|---|---|---|
| Min | Max | |
| ASSAY | 97.5 | 102.50% |
| WATER DETERMINATION | 0.50% | |
| RESIDUE ON IGNITION | 0.50% | |
| ELEMENTAL IMPURITIES | AS REPORTED | AS REPORTED |
| ORGANIC IMPURITIES DETECTED AT (UV 240 nm): | ||
| Bispirone related compound A | 0.10% | |
| Spiroammonium salt | 0.10% | |
| Bispyrimidinylpiperazinyl butane | 0.10% | |
| Bispyrimidinylpiperazinyl butyl ether | 0.10% | |
| Buspirone open ring | 0.30% | |
| Buspirone open ring dimer | 0.10% | |
| Buspirone related compound G | 0.10% | |
| Buspirone diester dimer | 0.10% | |
| Chlorobuspirone | 0.10% | |
| Buspirone open ring spirodimer | 0.20% | |
| Any other individual imputiry. | 0.10% | |
| Total impurities. | 0.40% | |
| ORGANIC IMPURITIES DETECTED AT (UV 210 nm): | ||
| Buspirone related compound K | 0.10% | |
| Buspirone related compound L | 0.10% | |
| Buspirone bromobutyl analog | 0.10% | |
| Buspirone related compound N | 0.10% | |
| Any other individual imputiry | 0.10% | |
| Total impurities | 0.20% | |
| IDENTIFICATION (A) | SPECTRUM MATCHES | SPECTRUM MATCHES |
| IDENTIFICATION (B) | RETENTION TIME | RETENTION TIME |
| IDENTIFICATION (C) | POSITIVE FOR CHL | POSITIVE FOR CHL |
| EXPIRATION DATE | ||
| DATE OF MANUFACTURE | ||
| APPEARANCE | ||
| RESIDUAL SOLVENTS | TO PASS TEST | TO PASS TEST |
