Cephradine, 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.

Therapeutical category:
Oral, broad spectrum cephalosporin.

Pharmacopoeia quality:
- USP
- Ph.Eur.
- BP
latest editions

Regulatory information:
EU: EDQM
Taiwan: Department of Health
USA: FDA

Packaging & shipping:
quantity per package: 25 kgs
approx. gross weight: 27.2 kgs
quantity per pallet: 300 kgs
approx. gross weight: 338 kgs

One polyethylene bag in aluminium bag in a 70 ltr double carton box
box size (l x w x h) = 39 x 39 x 49.5 cm
pallet loaded l x w x h = 120 x 80 x 114 cm
12 drums (2 layers of 6)

Appearance:
White or slightly yellow granules.

Content (HPLC):
cephradine + cephalexin
"on dry": 95.0 - 102.0 %.

Absorbance (Ph.Eur.):
262 nm: 215 - 240.
330 nm: 0.05.

Appearance of solution ( Ph.Eur.):
Not more opalescent than reference suspension II.

Absorbance 450 nm:
0.600.

pH:
3.5 - 6.0.

Water (Karl Fischer):
≤ 6.0 %.

Dimethylaniline:
Absent.

Bulk density (USP):
>0.75 g/ml.

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

Storage conditions:
Below 8 degrees, protected from light and moisture.