Carbocisteine
Carbocisteine EP5 standard, normal, micronized and compacted.GMP available.
Item | Specification: EP5 | Result |
Appearance | A white crystalline powder, practically insoluble in water, in alcohol and in ether. It dissolves in dilute mineral acids and in dilute solutions of alkali hydroxides | Conforms |
Identification | As per EP5 A; B; C | Conforms |
PH | 2.8 to 3.0 | 2.9 |
Specific Rotation [a]D20o | -32.5 o to- 35.5 o | -33.6 o |
State of Solution | 95.0% Min | 99.7% |
Ninhydrin-positive subs | 0.5% Max | Conforms |
Chloride (Cl) | 0.15% Max | 0.04% Max |
Sulfate (SO4) | 0.03% Max | 0.020% Max |
Iron (Fe) | 0.001% Max | 0.0005% Max |
Heavy Metals (Pb) | 0.001% Max | 0.0005% Max |
Loss on Drying | 0.5% Max | 0.2% |
Residue in Ignition | 0.3% Max | 0.05% |
Assay | 98.5 to 101.0% | 100.1% |
Conclusion: | Conforms to EP5 |