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
mixtures with clavulanate potassium.
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:
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 (25 kg) marked with a PurimoxTM holographic sticker on
the label.
Box dimensions (l x w x h): 39 x 39 x 49,5 (cm).
