Identification and analysis of an impurity inducing clinical adverse effect in anti-adhesion carboxymethyl chitosan products

- The impurity in CMC is identified as diglycolic acid.
- Pharmacological test indicated that diglycolic acid can cause BCT.
- We established the refined method to eliminate the diglycolic acid in drug products.
- Based on our findings, CFDA had issued a notice of companies to resume CMC products.