Ampicillin anhydrous, compacted

Characteristics:
A crystalline powder.

Application:
The product is suitable for the manufacture of 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
Europe: Council of Europe.

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 (22 pallets)
FCL (40 Ft container): 13800 (46 pallets)

 Appearance:
White, or almost white crystalline granules. 

Assay (HPLC):
On dry: 96.6 - 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):
<1.0%.

Dimethylaniline:
Absent.

Particle size (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.