Product  name

Ivermectin

Batch  NO

20200528

Quantity  

200kg

Package 

25kg/drum

Manufacturing date

28/05/2020

Reportin date

29/05/2022

Valid Till

2022.05

Based on

EP 8.0

Test  

Specification and limit

Result 

Description 

white crystalline powder

white crystalline powder

Identification

• Infra-red spectrum
• HPLC

• Infra-red spectrum of the sample should correspond to that of the reference standard
• The chromatogram of the assay preparation exhibits major peaks for component H₂B_1a,and  component H₂B_1b, the retention thimes and sizes of which correspond to those exhibited in the chromatogram of the standard preparation

• Corresponds to that of the reference standard spectrum
• The retention times and sizes correpond to those in the chromatogram of the standard preparation

Appearance of solution

the solution is clear and not more intensely coloured than reference solution BY7

Clear

Specific  rotation

- 17°--- -20°

-17.6

Water

≤1.0%

0.2%

Sulphated Ash

Not more than 0.1%

0.07%

Heavy metals

Not more than 20PPM

Less than 20 PPM

Limit of alcohol

Less than 5.0%

3.2%

Limit of formamide

Less than 3.0%

2.6%

Limit of methanol

Not more than 3000PPM

315PPM

Limit of toluene

Not more than 890PPM

Lower than (LOD=4.31PPM)

Related substance RRT 1.3-1.5

Not more than 2.5%

2.0%

Impurities at RRT 1.3-1.5

Not more than 1%

0.50%

Total

Not more than 5%

3.5%

Assay  H₂B_1a /(H₂B_1a+ H₂B_1b)

95.0%~102.0%

98.20%

Conclusion

In conformity with EP8.0