Product Name : Dexamethasone Sodium Phosphate
Molecular Formula : C22H28FNa2O8P
Molecular Weight : 516.40
Synonyms : : Pregna-1,4-diene-3,20-dione, 9-fluoro-11,17-dihydroxy-16-methyl-21-(phosphonooxy)-,disodium salt, (11ᵝ, 16α)-
CAS No : 2392-39-4
| Sr. No. | Test | Specifications |
|---|---|---|
| 1 | Description | White or slightly yellow, crystalline powder. Is odorless or has a slight odor of alcohol and is exceedingly hygroscopic. |
| 2 | Solubility | Freely soluble in water, slightly soluble in alcohol, very slightly soluble in dioxane, insoluble in chloroform and in ether. |
| 3 | Identification A) Infrared Absorption B) Phosphate C) Sodium |
The IR absorption spectrum of the test preparation should exhibit maxima at the same wavelength as that of a similar preparation of Dexamethasone Sodium Phosphate working standard. To comply To comply |
| 4 | Assay (On anhydrous and solvent-free basis) | Between 97.0% and 102.0% |
| 5 | Limit of Phosphate Ions | The absorbance of the sample solution is NMT that of standard solution. The limit is 1.0% of phosphate (PO4). |
| 6 | Limit of Alcohol |
Not more than 1.5% |
| 7 | Organic Impurities (By HPLC, %w/w) • 16(17)a-Homodexa-methasone sodium phosphate • 16(17)a-Homobeta-methasone sodium phosphate • 16(17)a-17R-Homodexa-methasone sodium phosphate • 13(17)a-Homodexa-methasone sodium phosphate • Betamethasone sodium phosphate • Dexamethasone ethyl ester • Dexamethasone • Fluroandrostadiene carboxylic acid • Dexamethasone sodium phosphate diester • Any other individual unspecified impurity • Total Impurities |
Not more than 0.2% Not more than 0.2% Not more than 0.2% Not more than 0.2% Not more than 0.2% Not more than 0.3% Not more than 0.5% Not more than 0.3% Not more than 0.1% Not more than 0.10% Not more than 1.0% |
| 8 | Optical Rotation |
Between +74° and +82° |
| 9 | pH |
Between 7.5 and 10.5 |
| 10 | Water content |
Not more than 10.0% |