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. The high tapped
bulk density makes the product suitable for the filling of 500 mg amoxicillin
in capsule size 0 and for filling of 250 mg amoxicillin in capsule size 2.
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 marked with a PuimoxTM holographic sticker on the label
box dimensions: 390 x 390 x 495 (mm)
