Quick Detail:
Spironolactone
Prodcut name: Spironolactone
Synonym: Aldactone;Antisterone;spirolactone;7-alpha-Acetylthio-3-oxo-17-alpha-pregn-4-ene-21,17-beta- carbolactone
CAS Registry Number: 52-01-7
Assay: 97.0%~103.0%
Packaging: 1kg/foil bag
Molecular Formula: C24H32O4S
Molecular Weight: 416.5735
Appearance: White or almost white fine crystalline powder;Slightly bitter taste, odourless or slightly mercaptan odor.Insoluble in water, soluble in ethanol, soluble in benzene or ethyl acetate.
Description:
It is a synthetic, steroidal antimineralocorticoid and antiandrogen that also has some weak progestogen properties, as well as some indirect estrogen and glucocorticoid effects. It is used primarily as a diuretic and antihypertensive, but may also be employed for the purpose of reducing elevated or unwanted androgen activity in the body.It acts predominantly as an antagonist of the mineralocorticoid (or aldosterone) and androgen receptors, and in relation to its antimineralocorticoid effects, belongs to a class of pharmaceutical drugs known as potassium-sparing diuretics.
Applications:
Spironolactone is competitive inhibition of aldosterone drugs, drug itself is not active, role is diuresis and endogenous competitive aldosterone antagonist and happen, belongs to the potassium diuretics.
Specifications:
Test Items |
Specification |
Test Results |
Appearance |
Almost white crystalline powder |
Almost white crystalline powder |
Identification |
Meet the requirements |
Meet the requirements |
Melting range |
198℃~209℃ Between 198℃ and 209℃ |
205.0℃~207.0℃ |
Specific rotation |
-33°~-37° Between -33° and -37° |
-35° |
Loss on drying |
≤0.5% Not more than 0.5% |
0.2% |
Limit of mercapto compounds |
Meet the requirements |
Meet the requirements |
Ordinary impurities |
Meet the requirements |
Meet the requirements |
Organic volatile impurities |
Meet the requirements |
Meet the requirements |
Assay(on the dried basis) |
97.0%~103.0%(C24H32O4S) Between 97.0% and 103.0% |
98.99% |
Conclusion |
Meet the requirements of USP29 |