Function: | Vitamins and Minerals Deficiency Drug |
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Grade Standard: | Medicine Grade |
Type: | Chemical Reagent |
State: | Powder |
Volatile: | Not Volatile |
Standard: | USP Ep |
Customization: |
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Product Name: | Milbemycin Oxime |
CAS: | 129496-10-2 |
MF: | 2C32H45NO7.2C31H43NO7 |
MW: | 2194.78 |
EINECS: | 206-141-6 |
Mol File: | 129496-10-2.mol |
Items | Specifications | Result |
Appearance | White or off-white powder | White powder |
Identification | IR: The IR spectrum of the substance to be examined corresponds to the spectrum of Milbemycin Oxime RS. | Conforms |
HPLC: Examine the chromatograms obtained in the assay, the 2 principal peaks in the chromatogram obtained with the test solution are similar in retention time to the 2 principal peaks chromatogram obtained with reference solution. | Conforms | |
Related substances | Impurity G: NMT2.0% | 0.15% |
Impurity E: NMT0.7% | 0.13% | |
Impurity H: NMT0.5% | 0.05% | |
Impurity I: NMT0.5% | Not detected | |
Any other unknow impurity: NMT0.3% | 0.15% | |
Total Impurities: NMT2.0% | 0.94% | |
Water | NMT 2.0% | 1.5% |
Residual Solvents | Ethano l NMT 5000ppm | 262ppm |
Aceton e NMT 5000ppm | Not detected | |
Dichloromethan e NMT 600ppm | 3ppm | |
N-Heptan e NMT 5000ppm | 12ppm | |
Chlorofor m NMT 60ppm | Not detected | |
Total Aerobic Bacteria | NMT 500CFU/g | <10cfu/g |
Total combined yeasts and molds | NMT 100CFU/g | <10cfu/g |
Escherichia coli | Absent/g | Absent |
Milbemycin Oxime (A3+A4) | 95.0A%~102.0%(Anhydrous substance) | 99.1% |
Ratio A4 (A3+A4) | Not less than 80% | 84% |
Conclusion | The product complies with the enterprise standard. The standard reference EP. |
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