Purimox® powder

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 (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:
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 corrugated cartboard box (25 kg)
box dimensions (l x w x h): 38 x 38 x 48 (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:
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 (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.

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

Shelf-life:

5 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.