Purimox®, extra dry

Characteristics:
a crystalline powder.

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 (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: 25 kg
approx gross weight: 26.7 kg
quantity per pallet: 400 kg
approx gross weight: 440 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): 38 x 38 x 48 (cm).

Appearance:
White or almost white powder.

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

Appearance of solution (HCl or NH₄OH) (Ph.Eur.):
not more opalescent than reference suspension II.

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

Wateractivity (Novasina TH 200):
≤ 0.3 at 25 °C.

Dimethylaniline:
absent.

Bulk density ( DIN ISO 787):
≥  0.28 g/ml.

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.