Purimox® Compacted Grade P (Amoxicillin Trihydrate)

Characteristics:
A white to almost white granular crystalline powder.

Application:
The product is suitable for the manufacture of amoxy-clav tablets. The appropriate excipients should be added.

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
India (MOH): available                                    

Packaging & shipping:
Available in 25kg HDPE drums.

Appearance:
A white to off-white crystalline powder.

Content (HPLC):
amoxicillin:                                                        
 "on dry": 97 .5 - 102.0% (typical: 99.0 % – 101.0 %)

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% w/w.

Dimethylaniline:
absent.

Tapped bulk density (DIN ISO 787):
≥ 0.70 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.