Oxaliplatin API

Oxaliplatin is an platinum-based antineoplastic agent used in cancer chemotherapy like:

  • Colon cancer in combination with 5-luorouracil/leucovorin
  • Gastric carcinoma, advanced or metastatic
  • Metastatic colorectal cancer in combination with cetuximab or bevacizumab and capecitabine
  • Metastatic pancreatic adenocarcinoma in combination with 5-fl uorouracil, leucovorin and irinotecan

Standard production

Quality: according to requirements • according to Ph.Eur. 7 – supplement 7.3 • according to USP 35

Regulatory information/Certification

GMP, EDQM Certifi cate of Suitability R0 -CEP 2011-395-Rev 00

Packaging and Shipping

Packaging Max. weight of the product in package Primary Packaging Secondary Packaging
Up to 5 kg 1 kg Brown bottle + cap, volume 1,0 l, weight 0,570 kg 18×10 cm Cardboard box, UN
Samples Max. weight of the product in package Primary Packaging Secondary Packaging
Up to 15 g 15 g Brown bottle 20 ml weight 42 g, height 5,5 cm , diameter 3cm Cardboard box, UN
Up to 50 g 50 g Brown bottle 60 ml weight 42 g, Height 5,5 cm , diameter 3cm Cardboard box, UN

Shelf-life

Two years

Storage conditions

Store below 25°C, in tight, light persistent container (absence of light is necessary)