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)