3,5-Pyridinedicarboxylicacid, 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-, methyl(1-oxobutoxy)methyl ester (9CI) Clevelox H 324/38
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ITEM |
STANDARD |
RESULT |
Appearance |
a white or almost white crystalline powder |
White powder |
Individual impurity |
≤0.1% |
0.08% |
Total impurity |
≤0.5% |
0.23% |
Ethanol |
≤0.5% |
N.D. |
Isopropanol |
≤0.5% |
N.D. |
Acetonitrile |
≤0.041% |
N.D. |
Chlorides |
≤0.02% |
<0.02% |
Residue on ignition |
≤0.2% |
0.08% |
Loss on drying |
≤0.5% |
0.11% |
Heavy metals |
≤0.002% |
<0.002% |
Assay (on dried base) |
98.5%~101.5% |
99.6% |
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