Items
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Specifications
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Results
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Appearance
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White to almost white powder
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White powder
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Identification
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HPLC retention time of sample complies with that of known sample
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Complies
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Specific rotation
|
[a]D20: +33.0°~+37.0°(C=1.0,CH3CN)
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+36.0°
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Water
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≤1.0%
|
0.31%
|
Related substances
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15R-Bimatoprost: ≤0.30%
|
Not detected
|
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Bimatoprostfree acid: ≤0.10%
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Not detected
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|
5,6-trans-Bimatoprost: ≤0.50%
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0.07%
|
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Any other single impurity: ≤0.10%
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0.05%
|
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Total other impurities: ≤ 0.50%
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0.18%
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Residual solvents
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Ter-Butylmethyl ether: ≤ 5000ppm
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Ter-Butylmethyl ether: ≤ 5000ppm
|
|
Ethanol: ≤5000ppm
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Ethanol: ≤5000ppm
|
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N-Hexane: ≤ 290ppm
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N-Hexane: ≤ 290ppm
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Ethyl acetate: ≤5000ppm
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Ethyl acetate: ≤5000ppm
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Purity
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≥99.5%
|
99.82%
|