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Ivermectin
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Product Name: Ivermectin Specification: EP6
Quantity: 200kg Batch No.: 20091212
Manuf. Date: Dec 2009 Exp. Date: Dec 2011
Item Specification Result
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Appearance White or yellowish-white crystalline powder Qualified
Identification:IR Corresponds with that of CRS standard Qualified
HPLC The retention time for H2B1a and H2B1b
correspond with that of standard preparation Qualified
Appearace of Solution Clear and not more intensely coloured than BY7 Qualified
Specific Optical Rotation
(anhydrous and solvent
-free substance) -17°~ -20° -18.6°
Impurities(RRT1.3-1.5)≤2.5 k: 2.14
J: 0.05
Any other impurities≤1 0.5 0.2
Related Substances 0.3 0.5
0.1 0.1
Total≤5 4.1
Disregard limit≤0.05 0.05
Ethanol and Formamide(%) Ethanol≤5.0 4.2
Formamide≤3.0 2.7
Heavy metal (%)(pb ppm) ≤20 20
Water (%) ≤1.0 0.3
Sulphated ash (%) ≤0.1 0.08
Residue of solvent(toluene) ≤890ppm Qualified
Assay (%) H2B1a/(H2B1a +H2B1b)≥90.0 95.9
(HPLC, Basis on drying) 95.0≤H2B1a +H2B1b≤102.0 95.1
Conclusion: Complies with the requirements of EP5
Ivermectin
