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Specification
Test Item | Analysis Specification | Result |
Description | white to off-white crystalline powder | white crystalline powder |
Identification IRspectrum | Meets the requirements | Meets the requirements |
UVspectrum | Meets the requirements | Meets the requirements |
Specific rotation | +324.~+328. | +327.7. |
Loss on drying(%) | 0.3max | 0.1 |
Residue on ignition(%) | 0.2max | 0.01 |
Heavy Metals(%) | 0.002max | <0.002 |
Limit of Lovastatin related compound A(%) | 0.5max | 0.22 |
Individual impurity (%) | 0.2max | 0.13 |
Total impurities (%) | 1.0max | 0.5 |
Assay(%) | 98.5~101.0 | 99.5 |