China (Mainland) 
|
items |
specifications |
results |
|
description |
white crystalline powder |
white crystalline powder |
|
solubility |
freely soluble in water and in glacial acetic acid, practically insoluble in acetone and in alcohol. |
consistent with the standard |
|
identification |
infrared absorption spectrophotometry(2.2.24); ir spectrum is in concordance with tranexamic acid crs |
consistent with the standard |
|
ph |
7.0~8.0 |
7.2 |
|
related substances liquid chromatography (2.2.29) |
impurity a:≤0.1% |
<0.1% |
|
impurity b:≤0.2% |
<0.2% |
|
|
any other impurity :≤0.1% |
<0.1% |
|
|
all other impurity: ≤0.2% |
<0.2% |
|
|
heavy metals |
≤10ppm |
<10ppm |
|
chlorides |
≤140ppm |
<140ppm |
|
loss on drying |
≤0.5% |
0.38% |
|
sulphated ash |
≤0.1% |
<0.10% |
|
assay(c8h15no2) |
99.0~101.0% |
99.80% |
|
conclusion: it conforms to the bp2009 standard. |
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application
hemostatic, a significant effect on traumatic bleeding, preoperative prophylactic medication can reduce surgical bleeding.
packing
25kg/fiber drum
