Product  name

BUDESONIDE

Batch No.

201011

Quantity

120g

Mfg. Date

Oct.,11, 2020

Expiry date

Oct.,11, 2022

Specification

EP6

Items

Standard

Results

Characters

A white or almost white crystalline powder,

practically insoluble in water, freely soluble in methylene chloride, sparingly soluble in alcohol.

white crystalline powder

Complies

Identification (A:IR)

Complies with the Standard  

Complies

Related Substances

-any impurity

Not more than 0.5%

0.22%

-sum impurities

Not more than 1.5%

0.44%

Epimer A

40.0%～51.0%  

42.0%

Methanol   

Not more than 0.1%  

Complies

Loss on drying

Not more than 0.5%  

0.02%

Assay(HPLC, basis on drying)

98.0%～102.0%    

99.6%

Organic volatile substances

Meet the ICH requirements

Complies

Packaging and storage: Preserve in tight, light-resistant containers.

Conclusion: The test product complies with the requirements of EP6.