CERTIFICATE OF ANALYSIS FOR IVERMECTI EP
|
Batch No.
|
Yw200909001
|
Batch size
|
100kg
|
MFG date
|
2009.09.04
|
|
Sampling date
|
2009.09.04
|
Test date
|
2009.09.04
|
Report date
|
2009.09.05
|
|
Reference
|
EP6
|
R test date
|
2011.09.03
|
|
Testing items
|
Specification. EP
|
Test results
|
|
Appearance
|
White or yellowish-white crystalline powder
|
White-crystalline powder
|
|
Appearance of solution
|
The solution is clear and mot more intensely coloured than reference solution BY7
|
clear
|
|
Identification
|
IR
|
Corresponds with that of CRS standard
|
complies
|
|
HPLC
|
The retention tine for H2B1a and H2B1b corresponds to CRS
|
Complies
|
|
Water
|
Not more than 1.0%
|
0.5
|
|
Ethanol
|
Not more than 5.0%
|
3.45
|
|
Formamide
|
Not more than 3.0%
|
2.73
|
|
Ratio H2B1a/(H2B1a+H2B1b),a
|
Not more than 90.0%
|
97.95
|
|
Assay(H2B1a+H2B1b) (Anhydrous and solvent-free substance)
|
Between 95.0% and 102.0%
|
95.40
|
|
Related compounds
|
Theindividual impurity(RRT1.3-1.5)
Not more than 2.5%
|
0.8 1.40
|
|
Any other individual impurity not more than 1%
|
0.1 0.49 0.02 0.50 0.55 0.03
|
|
Sum of total impurity not more than 5%
|
3.89
|
|
Disregard peaks less than 0.05%
|
0.05
|
|
Heavey metals
|
Not more than 0.002%
|
<0.002
|
|
Sulphated ash
|
Not more than 0.1
|
<0.1
|
|
Specific optical rotation(Anhydrous and solvent-free substance)
|
Between -17°-20°
|
-18°
|
|
Residual solvents(toluene)
|
Not more than 890ppm
|
<890ppm
|
|
Conclusion
|
Complies with the requirement of EP6
|