| Product Name | ivermectin |
| Appearance | White crystalline powder |
| CAS | |
| MF | C95H146O28 |
| Purity | 99%min vermectin |
| Application | Animal Pharmaceuticals, Human Pharmaceutical |
| Storage | store in cool & dry place,keep away from strong light and heat |
| Shelf Life | 24 months |
| Tests | Specification | Results | |
| Appearance | White or yellowish-white crystalline powder, slightly hygroscopic. | Yellowish-white crystalline powder, slight hygroscopic. | |
| Solubility | Practically insoluble in water, freely soluble in methylene chloride, soluble in alcohol. | Qualified | |
| Identification | IR | Corresponds to that of CRS standard | Qualified |
| HPLC | The retention time for H 2 Bla and H 2 Bl b in the chromatogram obtained with the test solution corresponds to those of standard preparation | Qualified | |
| Appearance of solution | Clear and not more intensely colored than BY? | Clear | |
| Specific optical rotation (anhydrous and solvent-free substance), ° | -20--17 | -17.9 | |
| Related substances (%) | Individual impurity(RRT 1.3-1.5)≤2.5 | I-l:<0.05 K:2.1 | |
| Any other impurity ≤ 1 |
C:0.06 A:0.57
J:0.14 H:0.39 D:<0.05 F:<0.05 E:0.36 1-2:0.19 |
||
| Total ≤5 | 3.8 | ||
| Disregard limit: 0.05 | |||
| Ethanol and Formamide (%) | Ethanol ≤5.0 | 3.9 | |
| Formamide≤3.0 | 2.5 | ||
| Catalyst (ug/g) | ≤1 | <1 | |
| Water (%) | ≤1.0 | 0.26 | |
| Sulphated ash (%) | ≤0.1 | 0.07 | |
| Heavy Metal (%) | ≤0.002 | <0.002 | |
| Assay (%) (HPLC, on dry basis) | H 2 Bl a /(H 2 Bl a +H 2 Bl b )≥90.0 | 97.7 | |
| 95.0≤H 2 Bl a +H 2 Bl b ≤ 102.0 | 96.7 | ||
| Conclusion | Complies with the requirements of EP10.0 | ||