Product Name

Betamethasone

Batch No.

20200801

MFG. Date

2020.08.01

Exp. Date

2022.07.31

Test Date

2020.08.01

Standard

EP6.0

ITEMS

SPECIFICATIONS

RESULTS

Character

White or almost white crystalline powder

White crystalline powder

Identification

B. Complies by IR

C. Complies by TLC

Conforms

Conforms

Test

Specific Rotation

+118^o to +126^o

+125.0^o

Related substances

Not more than one impurity between 0.5 to 1.0%

Principal impurity not more than 1.0%

Total impurities not more than 2.0%

Conforms

0.25%

0.99%

Loss on drying

Not more than 0.5%

0.06%

Assay

Contains 97.0% to 103.0% of C₂₂H₂₉FO₅ calculated on dried basis

98.89%

Conclusion

The goods conforms to EP6.0