IVERMECTIN

PRODUCT NAME: IVERMECTIN

EXPIRY DATE:2 years

CAS NO.:

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

APPEARANCE OF SOLUTION

CLEAR AND NOT MORE INTENSELY COLORED THAN BY7

Qualified

SPECIFIC OPTICAL ROTATION (ANHYDROUS AND SOLVENT-FREE SUBSTANCE), °

-17 ~ -20

-18.0

RELATED SUBSTANCES (%)

INDIVIDUAL IMPURITIES (RRT1.3-1.5) ≤2.5

imp1=0.3 imp2=1.9

ANY OTHER INDIVIDUAL IMPURITIES≤1

imp3=0.01 imp4=0.4

imp5=0.5 imp6=0.02

imp7=0.02 imp8=0.10

TOTAL≤5

3.25

DISREGARD LIMIT≤0.05

0.05

ETHANOL AND FORMAMIDE (%)

ETHANOL≤5.0

3.6

FORMAMIDE≤3.0

2.65

HEAVY METAL (%)

≤0.002

0.002

WATER (%)

≤1.0

0.50

SULPHATED ASH (%)

≤0.1

0.1

RESIDUE OF SOLVENT (TOLUENE)

≤890ppm

55

ASSAY (%)

(HPLC, BASIS ON DRYING)

H2B1a/(H2B1a+H2B1a) ≥90.0

97.0

95.0≤H2B1a+H2B1a≤102.0

95.5

CONCLUSION

COMPLIES WITH THE REQUIREMENTS OF EP6