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Ivermectin antiparasitic Ivermectin 70288-86-7
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96% Ivomec for Swine Ivermectina EP/USP grade raw material vet drug
Product Name
|
Ivermectin/ Ivermectina /Ivomec
|
Specification
|
EP10.0/ USP32.
|
Package
|
1kg/aluminum bag, 25bag/fiber durm
|
Shelf Life
|
2 years
|
Usage
|
Injection, oral solution, premix
|
TEST ITEMS |
SPECIFICATIONS |
RESULTS |
|
Appearance |
White or yellowish-white crystalline powder |
Qualified |
|
Solubility |
Practically insoluble in water; freely soluble in methylene chloride, soluble in alcohol (96%) |
Qualified |
|
Identification
|
IR |
Corresponds with that of CRS standard |
Qualified |
|
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 |
Qualified |
|
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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