Circumventing glass vial and diluent effects on solution stability of small molecule analytes during analytical method development and validation

Author:

Huang Yande,Hu Yue,Yuill Elizabeth M.,Marriott Andrew S.,Chadwick James,Li Jieming,Zang Jia,Miller Scott A.

Publisher

Elsevier BV

Subject

Clinical Biochemistry,Spectroscopy,Drug Discovery,Pharmaceutical Science,Analytical Chemistry

Reference13 articles.

1. United States Pharmacopeia and National Formulary (USP 38-NF 33), Rockville, MD: United States Pharmacopeia Convention, December 2015, General Chapter <661>: Containers-Plastics.

2. Impact of glass corrosion on drug substance stability;Watkins;J. Pharm. Sci.,2014

3. The importance of vial composition in HPLC analysis: an unusual case of phosphorous pseudorotation;Arvary;J. Pharm. Biomed. Anal.,2017

4. “Ghost peaks” of ezetimibe: solution degradation products of ezetimibe in acetonitrile induced by alkaline impurities from glass HPLC vials;Jin;J. Pharm. Biomed. Anal.,2017

5. Dissolution test of Tacrolimus capsule: effects of filtration and glass adsorption;Zeng;AAPS Pharm. Sci. Tech.,2018

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