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PRODUCT NAME: IVERMECTIN EXPIRY DATE:2 years CAS NO.: |
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TESTS |
SPECIFICATION |
RESULT |
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APPEARANCE |
White or yellowish-white crystalline powder |
Qualified |
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Identification |
IR |
Corresponds with that of CRS standard |
Qualified |
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HPLC |
The retention time for H2B1a and H2B1b corresponds with that of standard preparation |
Qualified |
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APPEARANCE OF SOLUTION |
CLEAR AND NOT MORE INTENSELY COLORED THAN BY7 |
Qualified |
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SPECIFIC OPTICAL ROTATION (ANHYDROUS AND SOLVENT-FREE SUBSTANCE), ° |
-17 ~ -20 |
-18.0 |
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RELATED SUBSTANCES (%) |
INDIVIDUAL IMPURITIES (RRT1.3-1.5) ≤2.5 |
imp1=0.3 imp2=1.9 |
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ANY OTHER INDIVIDUAL IMPURITIES≤1 |
imp3=0.01 imp4=0.4 imp5=0.5 imp6=0.02 imp7=0.02 imp8=0.10 |
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TOTAL≤5 |
3.25 |
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DISREGARD LIMIT≤0.05 |
0.05 |
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ETHANOL AND FORMAMIDE (%) |
ETHANOL≤5.0 |
3.6 |
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FORMAMIDE≤3.0 |
2.65 |
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HEAVY METAL (%) |
≤0.002 |
0.002 |
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WATER (%) |
≤1.0 |
0.50 |
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SULPHATED ASH (%) |
≤0.1 |
0.1 |
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RESIDUE OF SOLVENT (TOLUENE) |
≤890ppm |
55 |
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ASSAY (%) (HPLC, BASIS ON DRYING) |
H2B1a/(H2B1a+H2B1a) ≥90.0 |
97.0 |
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95.0≤H2B1a+H2B1a≤102.0 |
95.5 |
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CONCLUSION |
COMPLIES WITH THE REQUIREMENTS OF EP6 |
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