Dexamethasone Sodium Phosphate 55203-24-2

CEP, EP/USP

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Product Details

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 R_F value of the principal spot obtained from the test solution corresponds to that obtained from the standard solution.	Conforms
Identification	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
Residual solvents	Methanol ≤ 3000ppm	270ppm
Alcohol content	≤ 8.0%	Not detected
Chromtographic purity	Any individual impurity ≤ 1.0%	0.20%
Chromtographic purity	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

Basic Information

Dexamethasone Sodium Phosphate is a long-acting glucocorticoid drug. This drug belongs to the class of adrenocortical hormones and possesses anti-inflammatory, anti-allergic, anti-shock, and immunosuppressive effects.

Indications

Dexamethasone Sodium Phosphate is primarily indicated for the treatment of the following conditions:

(1) ‌Allergic and autoimmune inflammatory diseases‌: Including connective tissue diseases, active rheumatic diseases, rheumatoid arthritis, systemic lupus erythematosus, severe bronchial asthma, severe dermatitis, ulcerative colitis, etc.

(2) ‌Hematologic disorders‌: Such as acute leukemia and comprehensive treatment of malignant lymphoma

(3) ‌Severe infections and intoxications‌: As an adjunctive therapy

(4) ‌Special applications‌: Alleviation of cerebral edema caused by malignant tumors, certain pregnancy complications (e.g., promotion of fetal lung maturity), etc.

(5) Specific clinical application scenarios include: