98.0% up by HPLC Dexamethasone Sodium Phosphate 55203-24-2

Product Information

Product name

Dexamethasone Sodium Phosphate

CAS No.

55203-24-2

Molecular Formula

C22H28FNa2O8P

Molecular Weight

516.405

Quality Standard

98% up by HPLC, CEP, EP, USP

Appearance

White to slightly yellow crystalline powder

COA

Test Items

Specifications

Results

Appearance

White to slightly yellow crystalline powder, free from visible evidence of contamination, very hygroscopic.

White powder

Identification

A. The RF value of the principal spot obtained from the test solution corresponds to that obtained from the standard solution.

Conforms

B. The residue from the ignition of it meets the requirements of the tests for Phosphate and for Sodium.

Conforms

Assay (on anhydrous and solvent free basis)

97.0% - 102.0%

98.61%

Limit of phosphate ions

≤1.0%

0.03%

Water

≤16.0%

3.54%

Residual solvents

Acetone ≤ 5000ppm

9ppm

Methanol ≤ 3000ppm

270ppm

Alcohol content

≤ 8.0%

Not detected

Chromtographic purity

Any individual impurity ≤ 1.0%

0.20%

Total impurities ≤ 2.0%

0.40%

Limit of free dexamethasone

≤1.0%

<0.05%

Specific rotation

+74°~ +82°

+79°

pH

7.7 ~10.5

8.57

Microbial Limit

Aerobic Bacteria ≤ 1000cfu/g

< 10cfu/g

Mold and Yeast ≤ 100cfu/g

< 10cfu/g

E.Coli can not be detected

Not detected

Bacterial Endotoxin

<1.2EU/mg

<0.25EU/mg

Conclusion

It conforms to all the requirements of USP36.

Usage