| Article ID | Journal | Published Year | Pages | File Type |
|---|---|---|---|---|
| 7631484 | Journal of Pharmaceutical and Biomedical Analysis | 2013 | 7 Pages |
Abstract
- 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.
Keywords
Related Topics
Physical Sciences and Engineering
Chemistry
Analytical Chemistry
Authors
Ming-Ming Yu, Ting-Fu Jiang, Yuan-Hong Wang, Dong-Yan Wang, Zhi-Hua Lv,