Amoxicillin Trihydrate
For Direct Compression II, oral
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Application
Granules, produced by a patented Biochemie-process, with an increased bulk density and excellent flowability and compressibility. The material is particularly suitable for the production of dispersible tablets by direct compression after blending with appropriate excipients und lubricants.
Antibiotic category
Semisynthetic broad spectrum penicillin for oral use
Packaging
Storage
Store below 30°C,
Protect from light and moisture
Shelf life
60 months
Specification
| Appearance | white to whitish, crystalline granules |
|---|---|
| Solubility | slightly soluble in water |
| Specific optical rotation | +290° to +315° 1) |
| Bulk density | 0.55 - 0.75 g/ml |
| Water content (Karl Fischer) | 11.5 - 14.5 % |
| Clarity of solution (hydrochloric acid; Ph.Eur.) | not more opalescent than reference suspension II |
| Clarity of solution (ammonia; Ph.Eur.) | not more opalescent than reference suspension II |
| pH-value | 3.5 - 5.5 |
| Sulfated ash | not more than 1.0 % |
| Related substances (HPLC) | individual: not more than 1.0 % total: not more than 4.0 % |
| Assay | Amoxicillin (HPLC): 950 - 1020 µg/mg 1) 95.0 - 102.0 % 1) |
1) Based on the anhydrous substance
Remark
N,N-Dimethylaniline and dichloromethane are not used in the manufacturing process
Pharmacopoeial quality
USP, BP, Ph.Eur.
