78110-38-0 Aztreonam Aztreonam
Product Name: AZTREONAM
CAS No.:78110-38-0
Molecular FormulaC13H17N5O8S2
Formula Weight:435.44
Category:Sterile & Crude Raw Material(Active Drug)
Items |
Specification |
Analysis Result |
|
Appearance |
White, odorless crystalline powder |
Conform |
|
Identification |
The retention times of the major peaks in the chromatogram of the assay preparation correspond to those of the Standard preparation obtained in the assay |
Conform |
|
Color of Solution |
Not more than yellow or greenish- yellow Reference Solution II |
Conform |
|
Clarity of solution |
Not more than Turbidity Standard I |
Conform |
|
PH |
4.5~7.5 |
5.2 |
|
Related Impurities |
Single impurities |
Not more than1.0% |
0.34% |
Total impurities |
Not more than3.0% |
1.25% |
|
Water Content |
Not more than 2.0% |
0.3% |
|
Residue of ignition |
Not more than 0.1% |
Conform |
|
Heavy Metals |
Not more than 30ppm |
Conform |
|
Bacterial Endotoxins |
Not more than 0.17EU/mg (Aztreonam) |
Conform |
|
Sterility Test |
Sterile (without germs in 14 days) |
Conform |
|
Particulate matter |
≥10µm, no more than 2500/g ≥25µm, no more than 250/g |
1084 67 |
|
Assay |
Contain C13H17N5O8S2 90.0% ~105.0% (Calculated on anhydrous substance without L-Arginine ) |
99.5% |
|
L-Arginine content |
42%~45% |
43.4% |
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