Purimox® fine

Characteristics:
A crystalline powder.

Application:
The product is suitable for specific applications, for both human and veterinary use.

Therapeutical category:
Oral, broad spectrum penicillin.

Pharmacopoeia quality:
USP, Ph. Eur, BP (latest editions).

Regulatory information (dependent on manufacturing site):
Certification of Suitability of Monographs of the European Pharmacopoeia: available
USA (FDA): available                                         
Taiwan (DOH): available                                  
India (MOH): available                                     
Canada DMF: available

Packaging & shipping EA:
quantity per package: 20 kg
approx gross weight: 21.6 kg
quantity per pallet: 320 kg
approx gross weight: 361.6 kg

Inner package: a polyethylene bag inside a thermo sealed laminate bag.
Outer package: a corrugated cardboard box (25 kg); box dimensions (l x w x h): 29 x 39 x 49 (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% - 101.0%).

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):
≥ 0.40 g/ml.

Particle size distribution:
98% < 100μm.

Shelf-life:
4 years shelf life is available in the original packaging under 'storage conditions'.  

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

Sales specifications, valid at receipt by customer. Product will meet USP and EP monograph specifications throughout the assigned shelf life.