Purimox®

Characteristics:
A crystalline powder.

Application:
The product is suitable for the manufacture of granules for suspensions, dry powder mixtures for syrups and tablets. The appropriate excipients should be added. Purimox® Powder Extra Dry is available for formulations with Clavulanic Acid.  

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 (25 kg)
box dimensions (l x w x h): 39 x 39 x 49,5 (cm)

 Appearance:
A white to off-white crystalline powder.

Content (HPLC):
amoxicillin:
 "as is": 84.5 - 88.2%
 "on dry": 97.5 - 102.0% (typical: 99.0% - 100.0%).

Absorbance at 425 nm:
(10% w/v in buffer pH 9.2 after filtration, measured in a 1 cm cell)
≤ 0.050.

Appearance of solution: (Ph.Eur.)
not more opalescent than reference suspension II.

pH (Ph.Eur.):
3.5 - 5.5.

Water (Karl Fischer):
11.5 - 14.5%.

Dimethylaniline:
absent.

Bulk density ( DIN ISO 787):
≥ 0.20 g/ml.

Shelf-life:
6 years shelf life and 5 years shelf life for CEP is available in the original packaging under 'storage conditions'.  

Storage conditions:
below 25 °C, protected from light and moisture.