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Cephalexin monohydrate 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
China: SDA
Australia: TGA
USA: FDA
Taiwan: Department of Health
Canada: HPB
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 almost white granules.

Content (HPLC):
"on dry": 97.0 - 102.0%.

Absorbance (Ph .Eur.):
262 nm: 220 - 245.
330 nm: ≤ 0.05.

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

Water (Karl Fischer):
4.0 - 8.0%.

Dimethylaniline:
Absent.

Tapped bulk density (USP):
>
0.75 g/ml.

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

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

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