Amoxicillin trihydrate, Compacted for Direct Compression

Characteristics:
Granules obtained by means of dry compaction of the crystalline powder without adding any excipients.

Application:
The product is suitable for the manufacture of tablets produced by the direct compression process, after the addition of the appropriate excipients. The product is also suited for the manufacture of capsules on high speed machines.  

Therapeutical category:
Oral, broad spectrum penicillin.

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

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

Packaging & shipping:
quantity per package: 25 kgs
approx. gross weight: 26.6 kgs
quantity per pallet: 300 kgs
approx. gross weight: 334 kgs

One polyethylene bag and a sealed laminate bag
in a carton box, l x w x h = 39 x 39 x 50 cm
pallet loaded size l x w x h = 120 x 80 x 113 cm
12 boxes (2 layers of 6)
FCL (20 Ft container):   6600 kg (22 pallets)
FCL (40 Ft container): 13800 (46 pallets)

Appearance:
White to almost white granules  

Assay (HPLC):
"as is": 84.2 - 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 distribution (sieve method):
max 20%: < 125 µm
max 30%: < 250 µm
70-95%   :250 - 1000 µm
min 95%: < 1000 µm  

Tapped bulk density (DIN ISO 787):
0.7 - 0.80 g/ml

Shelf Life:
minimum 4 years in the original packaging under 'storage conditions'

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