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Safety and Toxicology
Chitosan Salts are manufactured in Sandvika, Norway in accordance with GMP guidelines; ICH Q7 and ISO standards; ISO 9001:2008, ISO 13485:2003 and ISO 22442:2007.
Ultrapure - UP - implies that the products contain low levels of residual endotoxin. The current specification is < 500 EU/g for the PROTASAN UP G 113 and <100 EU/g for the other PROTASAN UP Cl and UP G salts, and PROTASAN UP Base products. PROTASAN chitosans are ideal for a wide variety of pharmaceutical, biomedical, biotechnology and tissue engineering applications. The safety and toxicology profile of the ultrapure PROTASAN products are described in Drug Master Files submitted to the US FDA.
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