Ivermectin API

Product

Ivermectin

Batch No.

201307001

Manufacture Date

  2013.07.22

Quantity

200kg

Report Date

2013.07.24

Ref Standard

EP6

   Expiry Date

      2015.07.22

Items & Results

Item

Spec.

Result

Characters

White Or yellowish-white

crystalline powder 

White crystalline powder

Appearance of solution

Clear and not more intensely coloured than reference solution BY7

Clear

Identification

IR

Corresponds with that of CRS standard

Conforms

HPLC

The retention time for H2B1a and H2B1b Corresponds to CRS

Conforms

Water

  ≤1.0%

0.6

Ethanol

≤5.0%

3.6

Formamide

  ≤3.0%

2.6

   Related compounds

H2B1a isomers and 2.3 H2B1a ≤2.5%

0.3  1.75

Any other individual impurity 

≤1.0%

0.1  0.52  0.1  0.2  0.1  0.1

Sum of total impurities 

≤5.0%

3.17

Disregard peaks ≤0.05%

0.04

Heavy metals

   ≤0.002%

<0.001

Sulphated ash

≤0.1%

0.08

Specific optical rotation

 (°)

-17°~ -20°

       -18.2°

Residual solvents (Toluene)

≤890ppm

<890ppm

Assay (H2B1a+H2B1b)

95.0%~102.0%

96.70%

Ratio H2B1a/(B1a+B1b),a

≥90.0%

95.62%

Conclusion

Complies with the requirement of EP6.