Amoxicillin Trihydrate
compacted, oral
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Application
Granules with a high bulk density used for filling hard gelatine capsules. The material can be processed with any automatic capsule filling machine. A filling amount of about 300 mg of Amoxicillin Trihydrate compacted corresponds to 250 mg Amoxicillin, in capsule size 2. Approximately 600 mg of Amoxicillin Trihydrate compacted correspond to 500 mg Amoxicillin, in capsule size 0.
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 | +290° to +315° 1) |
| Bulk density | 0.55 - 0.75 g/ml |
| Tapped density | informative g/ml |
| Water content (Karl Fischer) | 11.5 - 14.5 % |
| Clarity of solution (hydrochloric acid; Ph.Eur.) | not more than reference suspension II |
| Clarity of solution (ammonia; Ph.Eur.) | not more 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.
