Ampicillin trihydrate 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
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: 28.2 kgs
quantity per pallet: 300 kgs
approx. gross weight: 360 kgs

one polyethylene bag and a sealed laminate bag in a carton box,
l x w x h = 38 x 38 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):
"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 (laser diffraction):
100% < 200 µm.

Bulk density ( DIN ISO 787):
> 0.25 g/ml.

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

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