Cephradine, non-sterile powder

Characteristics:
A crystalline powder.

Application:
The product is suited for the manufacture of granules for suspensions, dry powder mixtures for syrups and tablets. The appropriate excipients should be added.

Therapeutical category:
Oral, broad spectrum cephalosporin.

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

Regulatory information:
EU: EDQM
China: SDA
Taiwan: Department of Health

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 crystalline powder.

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 opalesc ent than reference suspension II.

Absorbance 450 nm:
0.60

pH:
3.5 - 6.0

Water (Karl Fischer):
≤ 6.0 %.

Dimethylaniline:
Absent.

Bulk density (USP):
>0.35 g/ml.

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

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