Product Name

Dexamethasone sodium phosphate

Batch No

201901209

Test Date

2019.12.24

Quantity  

10kg

According to

BP2005

MFG. Date

2019.12.24

Exp Date

2021.12.24

Test Items

Specification

Test Results

Character

White or almost white powder

Almost white powder

Identification

(1)

Complies by IR

Conforms

(2)

Complies by TLC

Conforms

Test

PH

7.5 to 9.5

8.6

Specific optical retation

+76^o to +82^o

+78.9^o

Related substances

Only one principal impurity more than 1.0% and not more than 2.0%

Conforms

Other impurity not more than 1.0%

Conforms

Inorganic phosphates

Not more than 1.0%

Conforms

Ethanol

Not more than 5000ppm

Undetected

Ethanol and water

Not more than 16.0%

3.6%

Assay

Contains 97.2% to 102.8% of C₂₂H₂₈FNa₂O₈P calculated with anhydrous ethanol-free

98.0%

Conclusion

The goods conforms to BP2005