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.
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.