This product is suitable for the manufacture of capsules after the addition of excipients such as magnesium stearate.

Amoxicillin trihydrate powder, extra dry

Characteristies:A crystalline powder.   Application:The product is suitable for the manufacture of mixtures with clavulanate potassium.   Therapeutical category:Oral, broad spectrum penicillin.   Pharmacopoeia quality:USP, Ph.Eur. & BP (latest editions). Regulatory information:USA: FDAEurope: Council of EuropeRussia: Ministry of HealthTaiwan: Department of Health and Council of AgricultureAustralia: Therapeutical Goods Administration Packaging & shipping:quantity per package: 25 kgsapprox. gross weight: 28.1 kgsquantity per pallet: 300 kgsapprox. gross weight: 350 kgs

Appearance:White or almost white powder  

Assay (HPLC):  "as is":  84.5 - 86.5%On dry:  97.5 - 102.0%  

Absorbance at 425 nm: (10% w/v in buffer pH 9.2 after filtration, measured in a 1 cm cell)  <0.050

Appearance of solution (Ph.Eur.)Not more opalescent than reference suspension II

pH (Ph.Eur.):  3.5 - 5.5

Wateractivity (Novasina TH 200):   < 0.3 at 25 °C

Dimethylaniline:Absent

Particle size (laser diffraction):100% < 200 µm

Bulk density ( DIN ISO 787):> 0.20 g/ml

Shelf Life:Minimum 5 years in the original packaging under 'storage conditions'

Storage conditions:  Below 25 °C, protected from light and moisture

Amoxicillin Compacted