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
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.
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.
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.
||White or almost white crystalline powder
||+75 º to +80 º
||Complies by IR
Complies by TLC
||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%
||97.0% to 102.0%