Dexamethasone Sodium Phosphate

Uses: It is an adrenal cortex hormone drug with anti-inflammatory, anti-toxic and anti-allergic effects.

Properties: This product is white to slightly yellow powder; odorless; hygroscopic.
Identification:

1. In the chromatogram recorded under the assay item, the retention time of the main peak of the test solution is consistent with the retention time of the main peak of the reference solution;

2. The infrared absorption spectrum of this product is consistent with the control spectrum (spectrum set 141);

3. The identification reaction of organic fluoride should be displayed;

4. The differential reaction of sodium salt and phosphate should be displayed.

Specific rotation: +72o - +80o

Alkalinity: PH value should be 7.5-10.5

Free phosphate: not greater than the absorbance of the control solution

Clarity and Color: The solution should be clear and colorless. If it is turbid, it must not be thicker than the No. 1 turbidity standard solution; if it is colored, it must not be darker than the yellow standard colorimetric solution.

Related substances: dexamethasone ≤0.5%, other individual impurities ≤0.5%, other impurities total ≤2.0%

Loss on drying: ≤15.0%

Residual solvent: acetone≤0.5%, methanol≤0.3%, ethanol≤0.5%

Residue on ignition: ≤0.1%

Microbial limit: the total number of aerobic bacteria ≤ 103cfu/g; mold and yeast ≤ 102cfu/g; no Escherichia coli was detected. Bacterial endotoxin≤1.2EU/g

Content: calculated as dry product, the content of C₂₂H₂₈FNa₂O₈P should be 96.0-102.0%.

Storage: shading, sealed, and stored in a dry place.