Specification No. B 13

BICALUTAMIDE

N-[4-cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl)sulfonyl]-2-hydroxy-2-methylpropanamide

Molecular Formula: C₁₈H₁₄F₄N₂SO₄
Molecular Weight: 430.37
CAS No. [90357-06-5]

Description: Slightly yellow, white to off-white hydrophobic powder. Freely soluble in dimethylformamide and acetone, soluble in methanol and practically insoluble in water.

Tests:	Limits:	Methods:
Identification: I.R. spectrum		USP 28 <197>
Water (K.F. titration):	max. 0.5 %	USP 28 <921> method I
Purity (HPLC):		USP 28 <621>
B-thiol:	max. 0.1 % Area	NQ B13, test No. 3
B-epoxide:	max. 0.1 % Area	NQ B13, test No. 4
B-diol:	max. 0.1 % Area	NQ B13, test No. 5
B-amide:	max. 0.1 % Area	NQ B13, test No. 6
B-sulfoxide:	max. 0.1 % Area	NQ B13, test No. 7
Any other individual impurity:	max. 0.1 % Area	NQ B13, test No. 9
Total sum of all impurities:	max. 0.5 % Area	NQ B13, test No. 10
Melting point	min. 185 °C	USP 28 <741>
The melting range does not exceed 3°C.
Heavy metals (calculation as lead):	max. 20 ppm	Ph. Eur. 5th Ed., <2.4.8>
Residue on ignition:	max. 0.1 %	NQ B13, test No. 13
Methanol (GC):	max. 1000 ppm	USP 28 <621> NQ B13, test No. 14
Microbiological test:
Bacteria	max. 1000 cfu/g	USP 28 <61>
Fungi	max. 100 cfu/g	USP 28 <61>
Escherichia coli	absent	USP 28 <61>
Salmonella	absent	USP 28 <61>
Staphylococcus aureus	absent	USP 28 <61>
Pseudomonas aeruginosa	absent	USP 28 <61>

B-thiol: N-[4-Cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl)thio]-2- hydroxy-2- methylpropanamide
B-epoxide: 4-cyano-N-(2,3-epoxy-2-methylpropionyl)-3-trifluoromethylaniline
B-diol: 4-cyano-N-(2,3-dihydroxy-2-methylpropionyl)-3-trifluoromethylaniline
B-amide: 4-cyano-N-methacryloyl-3-trifluoromethylaniline
B-sulfoxide: N-[4-Cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl)sulphinyl]-2-hydroxy-2-methylpropanamide
*NQ = Norm of Quality

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