Endotoxin Limits for Parenteral and Implanted Chitosan
The use of chitosans in biomedical and pharmaceutical applications continues to grow. This is especially true with tissue-engineered medical products (TEMPS) and use of chitosan as a transport facilitator or vehicle, such as in Drug Delivery. The existence and levels of impurities presented by the use of chitosan is a crucial consideration in these applications as dictated by regulatory and standards agencies, potential commercial partners, and advancing your R&D itself.
Whether your chitosan application utilizes medical-grade or ultimately pharmaceutical-grade chitosan, the endotoxin level in your chitosan supply can ultimately be critical in determining its use or non-use as a biomedical or pharma product. The regulatory and standards authorities in the US (FDA, USP, AAMI, ASMT, etc. and Europe (European Pharmacopoeia Commission (Ph. Eur.), etc.) continue to review and revise policies and guidance related to endotoxin levels in chitosan.
Therefore, it’s more important than ever to understand endotoxin limits for chitosan pharmaceutical and biomedical products. Especially for those where there are regulatory limits to the amount of endotoxin that can be implanted into humans.
The article above discusses endotoxin limits for parenterally administered drug products for human adults, for medical devices and for drug product components and excipients.
