Packaging & shipping AMEA Box:
quantity per package: 25 kgs
approx. gross weight: 27,5 kgs
Inner package: a polyethylene bag inside a thermo sealed laminate bag.
Outer package: a corrugated cardboard box (25 kg);
box dimensions ( l x w x h): 388 x 388 x 475 (mm).
Appearance:
White or almost white granules.
Content (HPLC) amoxicillin
"as is": 86.1 - 88.7%
"on dry": 97.5 - 102.0% (typical: 99.0% - 101.0%)
Appearance of solution (Ph.Eur.)
not more opalescent than reference suspension II
pH (pH.Eur.):
3.5 to 5.5.
Water (Karl Fisher):
11.5 - 14.5.
Dimethylaniline:
Absent (not used in manufacturing process).
Tapped density (USP II):
≥ 0.78 g/ml.
Water activity (Novasina):
≤ 0.3 at 25°C
Shelf life/Retest date (as applicable):
4 years in the original packaging under 'storage conditions'.
Storage conditions:
Below 25°C protected from light and moisture.
Sales specifications, valid at receipt by customer. Product will meet USP and EP monograph specifications throughout the assigned shelf life.
