Ampicillin trihydrate, compacted

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 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 ampicillin in capsule size 0. The product is also suitable for the manufacture of tablets.

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, Council of Agriculture.

Packaging & shipping:
quantity per package: 25 kgs
approx. gross weight: 27.5 kgs
quantity per pallet: 300 kgs
approx. gross weight: 343 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 115 cm
12 boxes (2 layers of 6)
FCL (20 Ft container): 6600 kg (22 pallets)
FCL (20 Ft container): 13800 (46 pallets)

Appearance:
White or almost white granules.

Assay (HPLC):
"as is": 84.2 - 86.8%
On anhydrous basis:  97.1 - 100.5%  

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):
12.0 - 15.0%.

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):
> 0.8 g/ml.

Shelf life:
Minimum 4 years in the original packaging under 'storage conditions'.

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