Product Name

Fluticasone propionate

Batch No.

20200407

MFG.  Date

Apr.01,2020

EXP. Date

Apr.01,2022

Package

100g/bag

Batch quantity

50KG

ITEMS

SPECIFICATIONS

RESULTS

Description

White or almost white ,crystalline powder

Almost white crystalline powder

Solubility

Practically insoluble in water,sparingly soluble methylene chloride,slightly soluble in ethanol(96perceng)

Conforms

Identification 

IR

A: Theinfrared absorption spectrum of test sample should conform to that of reference standard.

Conforms

HPLC

B:The principal peak in the chromatogram obtained with the test solution is similar in retention time to reference standard.

Conforms

Specific optical rotation  

+32°~ +36°

+35°

Water

≤0.5%

0.1%

Related substances

Impurity A

≤0.2%

0.02%

Impurity B

≤0.2%

0.05%

Impurity C

≤0.2%

0.08%

Impurity D

≤0.3%

0.2%

Impurity E

≤0.2%

＜0.02%

Impurity F

≤0.2%

＜0.02%

Impurity G

≤0.3%

0.06%

Impurity H

≤0.2%

0.06%

Impurity I

≤0.2%

0.02%

Any Impurity

≤0.1%

0.05%

Total impurity

≤1.2%

0.79%

Acetone

≤1.0%

Conforms

Assay

97.0%～102.0%

99.7%

Conclusion

Complies with EP8.0