Combating Alcohol Adduct Impurity in Immunosuppressant Drug Product Manufacturing: A Scientific Investigation for Enhanced Process Control

Author:

Sekar Vasanthakumar,Vedhachalam Devarajan,VB ArunKumar,Sivaraman Sivananthan,Janakarajan Venkatakrishnan,Sethuraman Sai,Shiroor Sandeep G.,Geoffroy Jean-Marie M.

Publisher

Springer Science and Business Media LLC

Reference36 articles.

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2. Sommers CD, Pang ES, Ghasriani H, Berendt RT, Vilker VL, Keire DA, et al. Analyses of marketplace tacrolimus drug product quality: Bioactivity, NMR and LC-MS. J Pharm Biomed Anal. 2013;85:108–17.

3. Staatz CE, Tett SE. Clinical pharmacokinetics of once-daily tacrolimus in solid-organ transplant patients. Clin Pharmacokinet. 2015;54:993–1025.

4. U.S. Food & Drug Administration: FDA. Drugs@FDA: FDA-approved drugs. In: US FDA. MD, FDA; 2023.

5. Bulusu MA, Baumann K, Stuetz A. Chemistry of the immunomodulatory macrolide ascomycin and related analogues. Prog Chem Org Nat Prod. 2011;94:59–126.

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