API TESTING SPECIFICATION

Name: Dexamethasone Sodium Phosphate USP

T.S.No.: SPEC/API/HDSP-019/D/01
Issue Date: 01/03/2006

Code: HDSP

CAS: 2392-39-4

Storage: Preserve in tight containers.

Supersede: SPEC/API/HDSP-019/D
Date: 01/04/2002

M.F.:  C22 H28 FNa2 O8 P

M.W.: 516.41g/mole

 

Test

 

Specification

Characters

:

White or slightly yellow, crystalline powder.It should odorless or has a slight odor of alcohol, and should hygroscopic.

Solubility

:

Freely soluble in water, slightly soluble in alcohol; very slightly soluble in dioxan, insoluble in chloroform, and in ether.

Identification A     (By IR)

:

The Rf value of the principal spot obtained from the test solution should correspond to that obtained from the standard solution.

Identification B     

:

The residue from the ignition of it should give the reactions of sodium and phosphates.

Specific rotation

:

Between + 74.000 to + 82.000 on dried basis.

pH

:

Between 7.50 to 10.50 pH

Water

:

The sum of the percentage of water content, and alcohol content should not be more than 16.00%w/w.

Limit of phosphate ions

:

Not More Than 1.00%w/w.

Free Dexamethasone    ( By HPLC )

:

Not More Than 1.00%w/w.

Chromatographic Purity

:

Any individual impurity: NMT 1.00%.

Total impurities : NMT 2.00%.

Organic volatile impurities

:

Meets the requirements.

Alcohol Contents

:

Not more than 8.00% w/w.

Residual solvents

 

Acetone not more than 5000.00 ppm.
Methanol not more than 3000.00 ppm.
Chloroform not ore than 30.00 ppm.
Isopropyl alcohol not more than 5000.00 ppm.
Tetra hydro furan not more than 720.00 ppm.

Assay

:

97.00 % to 102.00% w.r.t. water free and alcohol free basis.

End of specification