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ITEMS |
SPECIFICATION |
RESULTS |
DESCRIPTION |
WHITE OR ALMOST WHITE POWDER |
WHITE POWDER |
IDENTIFICATION |
CONFORM |
CONFORM |
CLARITY OF SOLUTION |
No more than #2 |
CONFORM |
ABSORBANCE OF SOLUTION (430nm) |
≤0.15 |
CONFORM |
PH |
8.0~10.0 |
9.0 |
SPECIFIC OPTICAL ROTATION |
+258°~+287° |
+273° |
BIGGEST IMPURUTY |
≤ 2.0 % |
0.8 % |
AMPICILLIN DIMER |
≤ 4.5 % |
3.4% |
N,N-DIMETHYLANILINE |
≤ 0.0020 % |
CONFORM |
2-ETHYLHEXANOIC ACID |
≤ 0.8 % |
0.005% |
METHYLENE CHLORIDE |
≤ 0.2 % |
0.2% |
HEAVY METAL |
≤ 0.0020 % |
< 0.0020 % |
WATER |
≤ 2.0 % |
0.9 % |
STERILITY |
CONFORM |
CONFORM |
BACTERIAL ENDOTOXINS |
CONFORM |
CONFORM |
ASSAY (AS ANHYDROUS SUBSTANCE) |
91.0~100.5% |
92.5 % |
CONCLUSION: THE ABOVE RESULTS COMPLY WITH EP6. |
CAS NO:15170-74-8
CAS NO:15170-74-8
CAS NO:15170-74-8
CAS NO:15170-74-8
CAS NO:15170-74-8
CAS NO:15170-74-8
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