阿莫西林三水酸, 超干轻粉

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: FDA
Europe: Council of Europe
Russia: Ministry of Health
Taiwan: Department of Health and Council of Agriculture
Australia: Therapeutical Goods Administration

Packaging & shipping:
quantity per package: 25 kgs
approx. gross weight: 28.1 kgs
quantity per pallet: 300 kgs
approx. gross weight: 350 kgs

One polyethylene bag and a sealed laminate bag
in a carton box,
box dimensions dependent of source either
l x w x h = 39 x 39 x 65 cm, or
l x w x h = 39 x 39 x 49 cm

Dimensions pallet loaded size either
l x w x h = 120 x 80 x 146 cm, or
l x w x h = 120 x 80 x 114 cm

12 boxes (2 layers of 6) 

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