Ampicillin Anhydrous
powder, oral
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Application
Universal quality used for the manufacture of granules for suspension, tablets, and film-coated tablets.
Antibiotic category
Semisynthetic broad spectrum penicillin for oral use
Packaging
Storage
Store below 30°C,
Protect from light and moisture
Shelf life
48 months
Specification
| Appearance | white or almost white, crystalline powder |
|---|---|
| Solubility | slightly soluble in water |
| Specific optical rotation | +280° to +305° 1) |
| Bulk density | 0.20 - 0.60 g/ml |
| Tapped density | informative g/ml |
| Water content (Karl Fischer) | not more than 2.0 % |
| Clarity of solution (hydrochloric acid; Ph.Eur.) | not more than slightly opalescent |
| Clarity of solution (ammonia; Ph.Eur.) | not more than slightly opalescent |
| pH-value | 3.5 - 5.5 |
| Sulfated ash | not more than 0.5 % |
| Related substances (HPLC) | total: not more than 3.0 % |
| Assay | Ampicillin (HPLC): 960 - 1005 µg/mg 1) 96.0 - 100.5 % 1) |
1) Based on the anhydrous substance
Remark
N,N-Dimethylaniline and dichloromethane are not used in the manufacturing process
Pharmacopoeial quality
USP, BP, Ph.Eur.
