Ivermectin is a highly effective anthelmintic and a widely used antiparasitic compound. Ivermectin powder is a white to off-white crystalline powder that is insoluble in water but soluble in organic solvents such as ethanol or methanol.
| TEST ITEMS | SPECIFICATIONS | RESULTS | |
| Appearance | White or yellowish-white crystalline powder | Conforms | |
| Solubility | Practically insoluble in water; freely soluble in methylene chloride, soluble in alcohol (96%) | Conforms | |
| Identification | IR | Corresponds with that of CRS standard | Conforms |
| HPLC | The retention time for H2B1a and H2B1b corresponds with that of standard preparation | ||
| Appearance of solution | Clear and not more intensely colored than BY7 | Conforms | |
| Specific optical rotation (anhydrous and solvent-free substance) | -17°～-20° | -17.7° | |
| Ethanol and Formamide (%) | Ethanol ≤5.0 | 3.9 | |
| Formamide ≤3.0 | 2.8 | ||
| Water（%） | ≤1.0 | 0.11 | |
| Sulphated ash (%) | ≤ 0.1 | 0.08 | |
| Heavy metals (%) | ≤ 0.002 | ＜0.002 | |
| Cat(ug/g) | ≤1.0 | ＜1 | |
| Related substances（%） | Individual impurity (RRT1.3-1.5)≤2.5 | I-1<0.05 K:2.1 | |
| Any other individual impurity≤1.0 | C:<0.05 A:0.53 J:0.20 H:0.30 D:0.07 F:0.07 E:0.63 I-2:0.16 | ||
| Total impurities≤5.0 | 4.1 | ||
| Disregard limit≤0.05 | 0.05 | ||
| Assay（%）HPLC (on dry baiss) | H2B1a/(H2B1a + H2B1b)≥90.0 | 96.9 | |
| 95.0≤(H2B1a + H2B1b)≤102.0 | 96.0% | ||
| Conclusion | Complies wtih the requirements of EP 9.0 | ||
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