ITEM

SPECIFICATIONS

RESULT

Description

Appearance

White or almost white powders

Almost white powders

Identification (IR)

Complies with spectrum of flubendazol CRS

Complies

Related Substances

Total Impurities

≤1.5%

1.3%

Individual Specified

Impurity A

≤0.25%

0.13%

Impurity B

≤0.25%

0.07%

Impurity C

≤0.25%

0.06%

Impurity D

≤0.25%

0.09%

Impurity E

≤0.25%

0.18%

Impurity F

≤0.5%

0.24%

Impurity G

≤0.25%

0.24%

Any other impurity with a relative retention between 1.2 and 1.3

≤0.25%

0.08% (RRT:0.24)

0.07% (RRT:0.24)

0.05% (RRT:1.28)

0.05% (RRT:1.30)

Any Other Impurity

≤0.10%

0.05% (RRT:1.33)

Loss on Drying

≤0.5%

0.30%

Sulphated Ash

≤0.1%

0.03%

Residual solvent

Methanol

≤3000ppm

541PPM

Benzene

≤2ppm

2PPM

Assay

99.0%~101.0% calculated on the dry basis

99.8%

Assay of Polymorphic b (IR)

≥90.0%

98.0%

CONCLUSION :The items tested meet the requirement of EUROPEAN PHARMACOPOEIA 7.0