Purimox®, compacted for direct compression CEP

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 capsules and tablets. The product is suitable for the filling of 250 mg amoxicillin in capsule size 1.

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 to off-white granules.

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):
not more opalescent than reference suspension II.

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

Water (Karl Fischer):  
11.5 - 14.5%.

Dimethylaniline:
absent.

Tapped bulk density (1250taps) DIN ISO 787:
0.7 - 0.9 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.