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.)
A. IR–spectrum (USP) B. TLC (Ph.Eur.) B. UV absorption (USP) C. Colour reaction (Ph.Eur.) C. Precipitate reaction (USP) |
Meet the requirement
Meet the requirement Meet the requirement Meet the requirement Meet the requirement Meet the requirement |
Complies
Complies Complies Complies Complies Complies |
Loss on drying
(Ph.Eur.) (USP) |
Not more than 0.5% Not more than 0.5% |
0.24% 0.23% |
Specific optical rotation
(Ph.Eur.) (USP) |
-41°~-46° -41°~-45° |
-43.4° -44.3° |
Sulphated ash (Ph.Eur.) | ≤0.1% | 0.02% |
Related substances (Ph.Eur.) | ||
Impurity A
Impurity B Impurity C Impurity D Impurity E Impurity I Any unspecified impurity Total |
≤0.2%
≤0.3% ≤0.2% ≤0.15% ≤0.3% ≤0.5% ≤0.10% ≤0.7% |
N.D.
N.D. N.D. N.D. N.D. 0.07% Complies 0.16% |
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
HPLC (Ph.Eur.) HPLC (USP) |
97.5%~102.0% 97.5%~103.0% |
100.2% 99.8% |
Residual solvent (In-house)
Methanol Tetrahydrofuran DMF |
≤3000ppm ≤720ppm ≤880ppm |
56ppm ≤LOD (0.0046ppm) ≤LOD (0.23ppm) |
Particle size (In-house) | 95%≤ 20 microns | Complies |
Conclusion | Compiles with EP8/USP38 |
Product name: Spironolactone,Aldactone CAS No.: 52-01-7 Molecular Formula: C24H32O4S Molecular Weight: 416.57 Assay: 99% Quality Standard: EP Packing: 1kg/tin Appearance: White or almost white fine crystalline powder Product Description: Spironolactone is a synthetic, steroidal ...
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