Product name

16α-Hydroxyprednisolone;

16α-Hydroxy prednisolone;

16alpha-Hydroxyprednisolone；

11a,16b,17,21-Tetrahydroxy-pregna-1,4-diene-3,20-dione；

budesonide intermediate；

16Α-Hydroxy-Prednisolone；

Budesonide Hydrolysate；

Budesonide Impurity A

CAS No.

13951-70-7

Molecular Formula

C21H28O6

Molecular Weight

376.45

Quality Standard

99% up by HPLC

Appearance

White to off white crystalline powder

COA

ANALYSIS

SPECIFICATION

RESULTS

Appearance

White to off white crystalline powder

Off white crystalline powder

Solubility

Sparingly soluble in Methanol.(0.1 g of sample in 10 ml of methanol)

Conforms

Loss on drying

≤0.5%

0.07%

Specific optical rotation

+71° ~ +79°

+71.7°

Relative substance

(HPLC)

1,2-Dihydronot?≤?0.15%

0.07%

Single impurity?≤?0.2%

0.11%

16α-Hydroxy prednisolone 21-acetate?≤0.10%

ND

Total impurity?≤1.0%

0.18%

Assay(HPLC)

≥99.0%

100.2%

Conclusion

The sample complies with the Requirements of In Enterprise Specifications.

Usage