1. Quick Detail:
Betamethasone Sodium Phosphate
English Synonyms: BETMETHASONE DISODIUM PHOSPHATE;bentelan;betamethasone 21-phosphate sodium;20-dione,9-fluoro-11-beta,17,21-trihydroxy-16-beta-methyl-pregna-4-diene-3;21-(dihydrogenphosphate),disodiumsalt;bentelan;betamethasonedisodiumphosphate;BETMETHASONE DISODIUM PHOSPHATE;betnesol;BETAMETHASONE 21-DISODIUM PHOSPHATE;betamethasone 21-phosphate disodium
CAS NO.: 151-73-5
Assay: 98%
Molecular Formula:C22H28FNa2O8P
Molecular Weight:516.4
Specifications: CP05
Packing:1kg/tin
Usage: Hormone, has anti-inflammatory effects
Appearance: It is is a white to practically white, odorless powder, and is hygroscopic.
It is freely soluble in water and in methanol, but is practically insoluble in acetone and in chloroform.
2. Description:
Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, USP is a sterile aqueous suspension containing betamethasone 3 mg per milliliter as betamethasone sodium phosphate, and betamethasone acetate 3 mg per milliliter. Inactive ingredients per mL: dibasic sodium phosphate 7.1 mg; monobasic sodium phosphate 3.4 mg; edetate disodium 0.1 mg; and benzalkonium chloride 0.2 mg as a preservative. The pH is adjusted to between 6.8 and 7.2.
The formula for betamethasone sodium phosphate is C22H28FNa2O8P and it has a molecular weight of 516.40. Chemically, it is 9-Fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 21-(disodium phosphate).
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The formula for betamethasone acetate is C24H31FO6 and it has a molecular weight of 434.50. Chemically, it is 9-Fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 21-acetate.
Betamethasone sodium phosphate is a white to practically white, odorless powder, and is hygroscopic. It is freely soluble in water and in methanol, but is practically insoluble in acetone and in chloroform.
Betamethasone acetate is a white to creamy white, odorless powder that sinters and resolidifies at about 165ºC, and remelts at about 200ºC-220ºC with decomposition. It is practically insoluble in water, but freely soluble in acetone, and is soluble in alcohol and in chloroform.
3.Application:
Glucocorticoids, naturally occurring and synthetic, are adrenocortical sterthat are readily absorbed from the gastrointestinal tract.
Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their anti-inflammatory effects in disorders of many organ systems. A derivative of prednilone, betamethasone has a 16β-methyl group that enhances the anti-inflammatory action of the molecule and reduces the sodium- and water-retaining properties of the fluorine atom bound at carbon 9.
Betamethasone sodium phosphate, a soluble ester, provides prompt activity, while betamethasone acetate is only slightly soluble and affords sustained activity.
4. Specification
Test item |
Specifications |
Character |
White or almost white crystalline powder |
Specific rotation |
+75 º to +80 º |
Identification |
Complies by IR
Complies by TLC |
Chromatographic purity |
Only one principal impurity more than 1.0% and not more than 2.0. other impurity not more than 1.0% |
Loss on drying |
Not more than 0.5% |
Chloroform |
≤60ppm |
Assay |
97.0% to 102.0% |