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Cephalexin monohydrate, powder


Characteristics:
A crystalline powder.

Application:
the product is suitable 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
Australia: TGA
USA: FDA
Taiwan: Department of Health
Canada: HPB
India: Ministry of Health and Family Welfare

Packaging & shipping boxes
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 46.5 cm
pallet loaded l x w x h = 120 x 80 x 114 cm
12 drums ( 2 layers of 6)

Appearance:
White to almost white crystalline powder.

Content (HPLC):
cephalexin

"on dry": 97.0 - 102.0%.

pH (Ph.Eur.):
4.0 - 5.5.

Water (Karl Fischer):
4.0 - 8.0%.

Dimethylaniline:
absent.

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

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

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