Amoxicillin Trihydrate
powder, oral
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Application
Universal quality with good mixing, granulating, and suspending properties. It is mainly used for the manufacture of granules for suspension and dry powder mixtures for suspension with the help of conventional technologies, and for the manufacture of tablets, as well as film-coated tablets.
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 or almost white, crystalline powder |
|---|---|
| Solubility | slightly soluble in water |
| Specific optical rotation | +290° to +315° 1) |
| Bulk density | 0.25 - 0.45 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.