Tranexamic acid
Synonyms:trans-4-Aminomethylcyclohexane-1-carboxylate; trans-4-(Aminomethyl)cyclohexanecarboxylic acid; Amstat
Molecular Formula C8H15NO2
Molecular Weight 157.21
CAS Registry Number 1197-18-8
EINECS 214-818-2
Category: Haemostatic
Characters
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White or almost white, crystalline powder
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Solubility
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Freely soluble in water and in glacial acetic acid, practically insoluble in acetone and in alcohol
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Identification
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IR absorption spectrophotometry is concordance with Tranexamic acid CRS
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PH
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7.0-8.0
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Related substances
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Impurity A: 0.1% max
Impurity B: 0.2%max
Any other impurity: 0.10% max
Sum of unspecified impurities: 0.2% max
Disregard limit: 0.025% max
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Halides expressed as chloride
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140ppm max
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Heavy metals
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10ppm max
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Loss on drying
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0.5% max
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Sulfated ash
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0.1% max
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Assay(titration)
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99.0% - 101.0%
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