Veterinary Medicine Antiparasitic Agent 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 H₂B1_b 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)

H₂B1_a/(H₂B1_a+H₂B1_a) ≥90.0

97.0

95.0≤H₂B1_a+H₂B1_a≤102.0

95.5

CONCLUSION

COMPLIES WITH THE REQUIREMENTS OF EP6