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. The
product is suitable for the filling of 250 mg amoxicillin in capsule size 1.
Therapeutical category:
Oral, broad spectrum penicillin.
Pharmacopoeia quality:
USP, Ph. Eur., BP (latest editions).
Regulatory information:
Certification of Suitability of Monographs
of the European Pharmacopoeia
Certificate No. R0-CEP 2001-367-Rev 01, 21
November 2002
USA (FDA): DMF 16950
Taiwan (DOH): REG - 023495 2002
India (MOH): BD-10 2002
Canada DMF-2003-001 2003
Packaging &
shipping:
quantity per package: 25 kg
approx gross weight: 26.6 kg
quantity per pallet: 300 kg
approx gross weight: 335.2 kg
Inner package: a polyethylene bag within a laminate bag
Outer package: a
corrugated carton box marketd with a PurimoxTM holographic sticker on the
label
box dimensions (l x w x h): 39 x 39 x 49,5 cm
