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Cefadroxil monohydrate, compacted


Characteristics:
granules obtained by means of dry compaction of the crystalline powder without adding any excipients.

Application:
the product is suited 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:
Taiwan: Dept. of Health
USA: FDA
EU: EDQM
India: Ministry of Health and Family Welfare

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 to slightly cream crystalline powder

Content (HPLC):
"on dry": 95.0 - 102. 0%

Absorbance (Ph.Eur.):
264 nm: 225 - 250
330 nm: ≤ 0.05

pH:
4.0 - 6.0

Water (Karl Fischer):
4.2 - 6.0%

Dimethylaniline:
absent

Tapped bulk density (USP):
>
0.80 g/ml

Shelf-life:
minimum 4 years in the orriginal packaging under 'storage conditions'

Storage conditions:
below 25 ºC, protected from light and moisture

For more information, please contact one of our local sales offices.


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