Spironolactone, Ph. Eur. grade CAS 52-01-7

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CAS: 52-01-7

MF: C₂₄H₃₂O₄S

MW: 416.58

Physical Description	White or pale yellow powder
Identification (IR)	To pass test A
Identification (TLC)	To pass test B
Identification	To pass test C
Specific Optical Rotation	-41.0 - -46.0 ° (dried substance)
Impurity A	≤ 0.2%
Impurity C	≤ 0.2%
Impurity D	≤ 0.15%
Impurity E	≤ 0.3%
Impurity F	≤ 0.3%
Impurity I	≤ 0.5%
Any Unspecified Impurity	≤ 0.1%
Total Impurities	≤ 0.7%
Free Thiol Compounds	To pass test
Chromium (Cr)	≤ 50ppm
Loss on Drying	≤ 0.5%
Sulfated Ash	≤ 0.1%
Assay (HPLC)	97.5 - 102.0 % (dried substance)
Pharmacopoeia Specification(s)	EP
Specification Version	1.0