Amoxicillin trihydrate, compacted grade A

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

Application:
This product is suitable for the manufacture of capsules after the addition of excipients such as magnesium stearate. The high tapped bulk density makes the product suitable for the filling of 500 mg amoxicillin in capsule size 0 and for filling of 250 mg amoxicillin in capsule size 2.  

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.

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 (22 pallets)
FCL (40 Ft container): 13800 (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.

Water (Karl Fischer):
11.5 - 14.5%.

Dimethylaniline:
Absent.

Particle size distribution (Alpine Sieve method):
max 40%: < 250 µm
60-95%: 250 - 1000 µm
min 95%: < 1000 µm  

Tapped Bulk Density (1250taps) 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.