Amstat 1197-18-8 Tranesamic acid
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Test Items |
Specification |
Test Results |
|
Characteristics |
White or almost white crystalline powder |
White crystalline powder |
|
Solubility |
Freely soluble in water and in glacial acetic acid, practically insoluble in acetone and in ethanol (96%). |
Conforms |
|
Identification |
Infrared absorption spectrophotometry (2.2.24):IR spectrum is in concordance with Tranexamic acid CRS |
Conforms |
|
PH(2.2.3) |
7.0~8.0 |
7.3 |
|
Chlorides (2.4.4) |
≤140ppm |
<140ppm |
|
Related substances (HPLC 2.2.29) |
Impurity A: ≤0.1% |
ND |
|
|
Impurity B: ≤0.2% |
0.04% |
|
|
Unspecified impurity: ≤0.1%
|
Impurity C Impurity D Other impurities |
0.002% 0.005% 0.03% |
|
All other impurity: ≤0.2% |
0.04% |
|
Loss on drying (2.2.34) |
≤0.5% |
0.1% |
|
Sulphated ash (2.4.14) |
≤0.1% |
<0.1% |
|
Heavy metals (2.4.8) |
≤10ppm |
<10ppm |
|
Assay (Titration 2.2.20) |
99.0%~101.0% |
100.1% |
|
Conclusion |
The product complies with prescribed standard of EP/BP |
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