Purimox® compacted grade A

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 after the addition of excipients such as magnesium stearate. The high tapped bulk density makes the product suitable for the filling of 500 mg amoxicillin in capsule size 0 and for filling of 250 mg amoxicillin in capsule size 2.  

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 AMEA box:
quantity per package: 25 kg
approx gross weight: 26,7 kg
quantity per pallet: 300 kg
approx gross weight: 351,6 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): 38 x 38 x 48 (cm).

Packaging & shipping AMEA drum:
quantity per package: 25 kg
approx gross weight: 28,4 kg
quantity per pallet: 300 kg
approx gross weight: 358,8 kg

Inner package: a polyethylene bag inside a thermo sealed laminate bag.
Outer package: a plastic drum (25 kg); drum dimensions (l x w x h): 38 x 38 x 60 (cm).

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): 29 x 39 x 49 (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) (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.

Tapped bulk density(1250taps) DIN ISO 787:
≥  0.8 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.