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Biapenem sterile 120410-24-4
Synonyms: 6-[[(4R,5S,6S)-2-Carboxy-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-en-3-yl]thio]-6,7-dihydro-5H-pyrazolo[1,2-a][1,2,4]triazol-4-ium inner salt
CAS NO.120410-24-4M.F:C15H18N4O4SM.W:350.39Appearance: White to pale yellow crystalline powder
Used for APIs
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Test items | Enterprise specification | Test results | |
Appearance | White to light yellow crystal or crystalline powder, no odor | White crystalline powder, no odor | |
Specific rotation | -27°~-34° | -32° | |
Identification | 1. Into 10mg of the substance to be examined, add 2ml of water for dissolving and 3ml of hydroxylamine hydrochloride solution, shake well, and allow to stand for 3min. Add 1ml of acid ferric ammonium sulfate, shake well, and then the solution shows red brown. 2. Add water to dilute 20mg of the substance to be examined to 100ml, accurately pipette 5ml, and dilute with water to 50ml, to obtain solution with concentration of 20ug/ml with water. The maximum absorption should exist at 293nm, and the minimum absorption should exist at 241nm. 3. In the chromatogram of the assay, the retention time of the major peak in the chromatogram obtained with the test solution corresponds to that of the major peak in the chromatogram obtained with reference solution. 4. The infrared spectrum of the substance to be examined corresponds to that of the reference spectrum. | 1.Conform 2.Conform 3.Conform 4.Conform | |
Acidity (10mg/ml) | 4.0~6.0 | 5.3 | |
Clarity of solution (10mg/ml) | No more pronounced than that of reference suspension I | Less pronounced than that of reference suspension I | |
Color of solution (10mg/ml) | No more intensely colored than the reference solution Yellow No.2 | Less intensely colored than the reference solution Yellow No.1 | |
Related substances | The biggest individual impurity | No more than 0.5% | 0.2% |
Total impurity | No more than 1.0% | 0.30% | |
Related substance A and related substance B | Total impurity no more than 0.5% | Not detected | |
Polymer | No more than 0.2% | 0.05% | |
Loss on drying | No more than 0.5% | 0.05% | |
Residue on ignition | No more than 0.1% | 0.04% | |
Heavy metal | No more than 0.0010% | Less than 0.0010% | |
Bacterial endotoxin | No more than 0.5EU/mg | Less than 0.5EU/mg | |
Report No.: 0004 | Batch No.: 1207004 | ||
Test items | Specification | Test results | |
Sterility | No growth of micro-organisms should occur after 14 days of incubation | No growth of micro-organisms occurs after 14 days of incubation | |
Residual solvents | Methanol | ≤0.3% | Not detected |
Tetrahydrofuran | ≤0.072% | Not detected | |
Acetonitrile | ≤0.041% | Not detected | |
N,N-dimethylformamide | ≤0.088% | Not detected | |
Ethanol | ≤0.5% | 0.2% | |
Assay (anhydrous) | Containing C15H18N4O4S≥98.0% | (Containing C15H18N4O4S) 100.6% | |
Particulate matter | >10μm: No more than 5000/vial >25μm: No more than 500 /vial | >10μm: 1273/vial >25μm: 30/vial | |
Biapenem sterile 120410-24-4