Amoxicillin trihydrate, powder

Characteristics:
A crystalline powder  

Application:
This product is suitable for the manufacture of blends for suspensions, dry mixtures for syrups and tablets. The appropriate excipients should be added.  

Therapeutical category:
Oral, broad spectrum penicillin.

Pharmacopoeia quality:
USP, Ph.Eur., BP (latest editions).

Regulatory information:
USA: FDA
EU: Council of Europe
Russia: Ministry of Health
Taiwan: Department of Health and Council of Agriculture
Australia: Therapeutic Goods Administration

Packaging & shipping:
quantity per package: 25 kgs
approx. gross weight: 28.2 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 on 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.

Water (Karl Fischer):
11.5 - 14.5.

Dimethylaniline:
Absent.

Particle size (Alpine Sieve method):
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.