Ampicillin Sodium CAS 69-52-3
Items |
Company standard |
Results |
Appearance |
White or almost white powder,hygroscopic |
White powder,hygroscopic, |
Solubility |
Freely soluble in water,sparingly soluble in acetone,practically insoluble in fatty oils and in liquid paraffin. |
Conforms |
Identification 1 |
The IR spectrum of the sample correspond to the IR spectrum of the ampicillin |
Conforms |
Identification 2 |
It gives reaction of sodium |
Conforms |
Appearance of solution |
Solution A and solution B are not more opalecent than refrence suspension Ⅱ |
Ⅰ- |
Absorbance(430nm) |
≤0.15 |
0.012 |
Specific optacal rotation |
+258° to +287° |
+275° |
pH |
8.0-10.0 |
9.5 |
Water |
≤1.0% |
0.36% |
Heavy metal |
≤20ppm |
Conforms |
Visible particles |
Practically particle-free |
Conforms |
Sub-Visible particles |
≥10um,≤4000particles/parts(2g) ≥25um,≤500particles/parts(2g) |
≥10um,509particles/parts(2g) ≥25um,20particles/parts(2g) |
Arsenic |
≤2ppm |
<2ppm |
Related substance(HPLC) |
Ampicillin dimer≤1.0% Any other impurity≤1.0% |
0.27% 0.26% |
Residual solvents |
Acetone ≤5000ppm Ethyl acetate≤5000ppm Isopropyl acetate≤5000ppm Isopropyl alcohol≤5000ppm Ethanol≤5000ppm Butyl acetate≤5000ppm Normal butanol≤5000ppm Methylene chloride≤600ppm Diisopropyl amine≤2695ppm |
Acetone 100ppm Ethyl acetate 100ppm Isopropyl acetate 100ppm Isopropyl alcohol 100ppm Ethanol N.D Butyl acetate 300ppm Normal butanol 1000ppm Methylene chloride N.D Diisopropyl amine 268ppm |
N,N-Dimethylanilline |
≤20ppm |
N.D |
2-Ethylhexanoic acid(GC) |
≤0.8% |
0.4% |
Assay |
91.0%-102.0%(anhydrous substance) |
99.2% |
Bacterial endotoxins |
<0.151IU/mg |
Conforms |
Sterility |
Conforms |
Conforms |
Caution |
Complies with the standard of EP/STP.601-03test |