Ampicillin Sodium
crystalline, sterile
|
 |
Application
This quality produced by sterile crystallization is suitable for aseptic filling into vials using any customary machine. A clear solution for injection is produced by adding water for injection and shaking for approx. 10 seconds.
Antibiotic category
Semisynthetic broad spectrum penicillin for parenteral use
Packaging
Storage
Store below 25°C,
Protect from light and moisture
Shelf life
60 months
Specification
| Appearance | white to whitish, crystalline powder |
|---|---|
| Specific optical rotation | +258° to +287° 1) |
| Absorbance (430 nm; Ph.Eur.) | not more than 0.15 |
| Water content (Karl Fischer) | not more than 2.0 % |
| Fibres & suspended matter | practically free from fibres & particulate matter |
| Particulate matter | not more than particle level 5 |
| Clarity of solution (water; Ph.Eur.) | clear |
| Clarity of solution (hydrochloric acid; Ph.Eur.) | not more opalescent than reference suspension II |
| pH-value | 8.0 - 10.0 |
| Heavy metals 2) (limit test) | not more than 20 ppm |
| Heavy metals 3) (AAS/ICP) | Sum of Hg, Pb, Cd, As, Cu, Ni: not more than 20 ppm Fe: not more than 20 ppm |
| 2-Ethylhexanoic acid (GC) | not more than 0.8 % |
| Sterility (USP/Ph.Eur.) | sterile |
| Bacterial endotoxins (LAL-test/USP) | not more than 0.150 EU/mg |
| Largest impurity | not more than 2.0 % |
| Ampicillin dimer | not more than 4.5 % |
| Assay |
|
1) Based on the anhydrous substance
2) This test is omitted if the test for heavy metals by atomic absorption spectroscopy or the ICP-OES procedure is carried out
3) This test is performed alternatively to the limit test for heavy metals.
Remark
N,N-Dimethylaniline and dichloromethane are not used in the manufacturing process
Pharmacopoeial quality
USP, BP, Ph.Eur.
