Purimox® compacted grade A

 
Characteristics:
Granules obtained by means of dry compaction of the crystalline powder without adding any excipients.

Application:
The product is suited 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:
Certification of Suitability of Monographs of the European Pharmacopoeia
Certificate No. R0-CEP 2001-367-Rev 01, 21 November 2002
USA (FDA): DMF 16950
Taiwan (DOH): REG - 023495 2002
India (MOH): BD-10 2002
Canada DMF-2003-001 2003

Packaging & Shipping
quantity per package: 25 kg
approx gross weight: 26.6 kg
quantity per pallet: 300 kg
approx gross weight: 335.2 kg

Inner package: a polyethylene bag within a laminate bag
Outer package: a corrugated carton box marked with a PuimoxTM holographic sticker on the label
box dimensions: 390 x 390 x 495 (mm)

 

 
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 %)

Absorbance at 425 nm:
(10% w/v in buffer pH 9.2 after filtration, measured in a 1 cm cell)
≤ 0.050

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

Tapped bulk density(1250taps) DIN ISO 787:
≥  0.8 g/ml

Shelf-life:
5 years shelf life and 4 years shelf life for CEP is available in the original packaging under 'storage conditions'

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