Amoxicillin Sodium
crystalline, sterile
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Application
This quality produced by sterile crystallization is suitable for aseptic filling into vials, bottles or other delivery systems 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
36 months
Specification
| Appearance | white to almost white, very hygroscopic crystalline powder |
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| Specific optical rotation | +240° to +290° 1) |
| Absorbance (430 nm; Ph.Eur.) | not more than 0.20 |
| Bulk density | 0.3 - 0.5 g/ml |
| Tapped density | informative g/ml |
| Water content (Karl Fischer) | not more than 3.0 % |
| visible particles | essentially free |
| subvisible particles | particles >= 10 µm: <= 6000 p/g particles >= 25 µm: <= 600 p/g |
| appearance of solution | not more opalescent than reference suspension II |
| pH-value | 8.0 - 10.0 |
| Heavy metals | not more than 20 ppm |
| 2-Ethylhexanoic acid (GC) | not more than 0.8 % |
| Sterility (USP/Ph.Eur.) | sterile |
| Bacterial endotoxins (LAL-test) | not more than 0.250 IU/mg |
| Amoxicillin dimer | not more than 3.0 % |
| Total impurities | not more than 9.0 % |
| Assay | Amoxicillin Sodium (HPLC): 89.0 - 102.0 % 1) |
1) Based on the anhydrous substance
Remark
N,N-Dimethylaniline and dichloromethane are not used in the manufacturing process
Pharmacopoeial quality
BP, Ph.Eur.
General information
This product may be subject to third party patents in certain countries. Clients are kindly requested to check patent situation with Sandoz.