Flutamide cas 13311-84-7 2-Methyl-N-(4-nitro-3-[trifluoromethyl]phenyl)propanamide
flutamide |
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flutamide 13311-84-7
2-Methyl-N-(4-nitro-3-[trifluoromethyl]phenyl)propanamide
Specification:
Items |
Acceptance criteria |
Results |
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Character |
Appearance: White or almost white powder. |
Almost white powder |
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Solubility: Slightly soluble in water, freely soluble in dilute acetic acid and in methanol, slightly soluble in alcohol. |
Complies |
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Identification |
A.Specific optical rotation: –30.0º~-33.5º (dried substance) |
–33.3º |
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B.Infrared absorption spectrophotometry: The IR spectrum is consistent with that obtained with Levodropropizine CRS. |
Complies |
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Tests |
pH |
9.2~10.2 |
9.4 |
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Impurity B and related substances |
Impurity B: ≤ 0.5% |
≤ 0.1% |
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Any other impurity: ≤ 0.1 % |
≤ 0.1% |
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Total impurities: ≤ 0.6 % |
≤ 0.1% |
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Impurity C |
≤ 5 ppm |
≤ 5ppm |
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Enantiomeric purity |
Impurity A: ≤ 2 % |
0.2 % |
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Loss on drying |
≤ 1.0 %. |
≤ 0.1% |
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Sulphated ash |
≤ 0.2 % |
≤ 0.1% |
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Assay |
98.5% ~ 101.0%(dried substance) |
99.7% |
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Conclusion |
The product meets the specification of EP7.0 |
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