Amoxicillin trihydrate, compacted extra dry

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 mixtures with potassium clavulanate.

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: 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 kg (46 pallets)

Appearance:
White or almost white granules.

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 distribution (sieve method):
max 40%: < 250 µm
60-95%: 250 - 1000 µm
min 95%: < 1000 µm  

Tapped bulk density (DIN ISO 787):
> 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.