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Category:Active Pharmaceutical Ingredients > Other Active Pharmaceutical Ingredients
Product Name:EP8; USP38, 99% up by HPLC Spironolactone 52-01-7
CAS No.:52-01-7
Standard:USP, BP, EP, JP, In-house Standards
Price(USD):Negotiable
Company:Sinoway Industrial Co. Ltd
Grade: Pharmaceutical Grade
Factory Location: Xiamen, Fujian
Main Sales Markets: North America,Central/South America,Western Europe,Eastern Europe,Australasia,Asia,Middle East
Monthly Production Capacity: 1000kg
Packaging Information: 25kg/drum 1kg/bottle
Delivery Lead Time: 7 days after payment
Sample Provided: yes
Payment Terms: L/L
Product Information |
Product name |
Spironolactone |
Molecular Formula |
C24H32O4S |
Molecular Weight |
416.57 |
CAS No. |
52-01-7 |
Quality Standard |
99% up, medical grade |
Appearance |
White powder |
COA of Spironolactone |
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 requirementMeet the requirementMeet the requirementMeet the requirementMeet the requirementMeet the requirement |
CompliesCompliesCompliesCompliesCompliesComplies |
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 AImpurity BImpurity CImpurity DImpurity EImpurity IAny unspecified impurityTotal |
≤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%Complies0.16% |
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 |
AssayHPLC (Ph.Eur.)HPLC (USP) |
97.5%~102.0%97.5%~103.0% |
100.2%99.8% |
Residual solvent (In-house)MethanolTetrahydrofuranDMF |
≤3000ppm≤720ppm≤880ppm |
56ppm≤LOD (0.0046ppm)≤LOD (0.23ppm) |
Particle size (In-house) |
95% ≤ 20 microns |
Complies |
Conclusion |
Compiles with EP8/USP38 |
Usage |
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