| Items |
Standard |
| 1.Characteristics |
Light white crystalline powder |
| 2.Specific rotation[a]D2o |
-0.5 o- +0.5 o |
| 3.Los on drying % |
≤4.0 |
| 4.Heavy metals % |
≤0.002 |
| 5.Free aromatic aminc % |
≤0.05 |
| 6.Free iodide % |
conforms |
| 7.Free iodide % |
≤0.002 |
| 8.Ionic compounds % |
≤0.05 |
9.Limit of methanol,
isopropyl,alchol,and
methoxyethanol % |
methanol ≤0.005
isopropyl aechot ≤0.01
methoxyethanol ≤0.01 |
| 10.Limit of 3-chloro-1,2-propanediol % |
≤0.01 |
| 11?Limit of o-alkylated compounds % |
≤0.6 |
| 12.Chromatographic purity(sum of impurities) % |
≤0.4 |
| 13.Assay % |
98.0-102.0 |