Ivermectin EP/USP high quality with GMP low price CAS NO.70288-86-7

tests

specification

result

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

corresponds with that of standard preparation

qualified

specific optical rotation (anhydrous and solvent-free substance), °

-17~ -20

-18.2

water (%)

≤1.0

0.1

residue on ignition (%)

≤0.1

＜0.1

heavy metal (%)

≤0.002

0.002

related substances (%)

h4b1a isomers and △2,3 h4 b1a≤2.5

1.9

8a-oxo- h2 b1a≤1

0.3

b1a≤0.7

0.4

any other individual impurity≤0.5

0.5

the sum of all other individual impurities≤1

1.0

the sum of all impurities≤4

3.6

ethanol and formamide (%)

ethanol≤5.0

4.0

formamide≤3.0

2.6

assay (%)

(hplc, basis on drying)

h2b1a/(h2b1a +h2b1b)≥90.0

98.2

95.0≤h2b1a +h2b1b≤102.0

96.6

residual solvents

methanol(ppm)

≤2000

＜182

benzene(ppm)

≤2

＜1.8

toluene(ppm)

≤890

＜0.70

note

item 3 and 9 calculated on the anhydrous and alcohol and formamide-free basis

conclusion

complies with the requirements of usp36