Industrial approaches and consideration of clinical relevance in setting impurity level specification for drug substances and drug products

Author:

Pokar Dhruvisha,Rajput Niraj,Sengupta PinakiORCID

Funder

National Institute of Pharmaceutical Education and Research- Ahmedabad

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference56 articles.

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2. A practical derivatization LC/MS approach for determination of trace level alkyl sulfonates and dialkyl sulfates genotoxic impurities in drug substances;An;J. Pharm. Biomed. Anal.,2008

3. Pharmaceutical impurities: regulatory perspective for abbreviated new drug applications;Basak;Adv. Drug Deliv. Rev.,2007

4. Establishing Patient centric specifications for drug substance and drug product impurities;Bercu;J. Pharm. Innov.,2019

5. BETA-PROPIOLACTONE - National Library of Medicine HSDB Database [WWWDocument], https://toxnet.nlm.nih.gov/cgibin/sis/search/a?dbs+hsdb:@term+@DOCNO+811 (accessed 11.20.19).

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