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Spironolactone 52-01-7 Spironolactone manufacturer
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Chemical Name:Spironolactone
CAS No.:52-01-7
Synonyms:Dira;Altex;Acelat;Aldace;Osiren;Osyrol;sc9420;Alderon;Aldopur;Almatol
CBNumber:CB9743463
Molecular Formula:C24H32O4S
Formula Weight:416.57
MOL File:52-01-7.mol
ITEMS | STANDARDS | RESULTS |
Appearance (Ph.Eur.) | A white or yellowish-white powder | White powder |
Solubility (Ph.Eur.) | Practically insoluble in water, soluble in ethanol (96%) | Complies |
Identification | ||
A. IR –spectrum (Ph.Eur.) | Meet the requirement | Complies |
A. IR –spectrum (USP) | Meet the requirement | Complies |
B. TLC (Ph.Eur.) | Meet the requirement | Complies |
B. UV absorption (USP) | Meet the requirement | Complies |
C. Colour reaction (Ph.Eur.) | Meet the requirement | Complies |
C. Precipitate reaction (USP) | Meet the requirement | Complies |
Specific optical rotation | -41°~-46° | -42.8° |
(Ph.Eur.) | -41°~-45° | -42.9° |
(USP) | ||
Sulphated ash (Ph.Eur.) | ≤0.1% | 0.00% |
Related substances (Ph.Eur.) | ||
Impurity A | ≤0.2% | N.D. |
Impurity B | ≤0.3% | N.D. |
Impurity C | ≤0.2% | N.D. |
Impurity D | ≤0.15% | N.D. |
Impurity E | ≤0.3% | N.D. |
Impurity I | ≤0.5% | 0.05% |
Any unspecified impurity | ≤0.10% | Complies |
Total | ≤0.7% | 0.13% |
Ordinary impurities (USP) | ≤2.0% | Complies |
Free thiol compounds (Ph.Eur.) | ≤0.05mL | Complies |
Free mercapto compounds (USP) | ≤0.10mL | Complies |
Chromium (Ph.Eur.) | ≤50ppm | Complies |
Assay | 97.5%~102.0% | 100.90% |
HPLC (Ph.Eur.) | 97.5%~103.0% | 99.60% |
HPLC (USP) | ||
Residual solvent (In-house) | ≤3000ppm | 90ppm |
Methanol | ≤720ppm | ≤LOD (0.0046ppm) |
Tetrahydrofuran | ≤880ppm | ≤LOD (0.23ppm) |
DMF | ||
Particle size (In-house) | 95% ≤ 20 microns | Complies |
Conclusion |
Compiles with EP7/USP35 |
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