Ampicillin anhydrous, powder

Characteristics:
A crystalline powder.

Application:
The product is suitable for the manufacture of blends for suspensions, dry powder mixtures for syrups and 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
EU: 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 65 cm
pallet loaded size l x w x h = 120 x 80 x 145 cm
12 boxes (2 layers of 6)
FCL (20 Ft container): 3300 (11 pallets)
FCL (40 Ft container): 6600 (22 pallets)

Appearance:
A white crystalline powder.

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 (laser diffraction):
100% < 200 µm.

Bulk density ( DIN ISO 787):
> 0.20 g/ml.

Shelf Life:
Minimum 5 years in the original packaging under 'storage conditions'.

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