Amoxicillin Trihydrate
microfine, oral
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Application
Micronized quality suitable for the production of oral solutions and suspensions.
Category
Semisynthetic broad spectrum penicillin for oral use
Packaging
Storage
Store below 25°C,
Protect from light and moisture
Shelf life
48 months
Specification
| Appearance | white to whitish, crystalline powder |
|---|---|
| Solubility | slightly soluble in water |
| Specific optical rotation | +290° to +315° 1) |
| Bulk density | 0.25 - 0.45 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.
