Listing ID #7091226
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TESTING |
SPECIFICATION |
RESULT |
Characteristics (IP/EP) |
It is white almost white powder |
White Powder |
Solubility (EP/IP/USP) |
Practically insoluble in water solubility anhydrous ethanol and |
Confirms |
Specific Rotation EP/IP/USP |
-Â Â Â Â Â Â Â 45áµ’ ~ -49áµ’ |
-Â Â Â Â Â Â Â 48áµ’ |
Identification   IR |
IR spectrum should meet the requirement |
Confirms |
                          HPLC |
LC chromatogram should meet the requirement |
Confirms |
Alkalinity   EP/IP/USP |
9.0~11.0 |
9.9 |
Solution clarity and color IP/EP |
Should be clear and colorless |
Confirms |
Crystallinity (USP) |
Birefringence and extinction Positions |
Confirms |
Water     EP/IP/USP |
4.0% ~ 5.0% |
4.5% |
Residue on ignition  IP/USP |
≤ 0.2% |
0.1% |
Heavy metal (IP) |
≤ 10 ppm |
Confirms  |
 |
Residual Solvents |
||
Benzene |
≤ 0.0002% |
Not Detected |
Methyl benzene |
≤ 0.089% |
0.0003% |
Triethyl amine |
≤ 0.032% |
0.0001% |
HPLC  Assay   USP |
C38H22N2O12 945 – 1030 g/ml |
988/mg |
 |
 |  |