Investigation of a Degradant in a Biologics Formulation Buffer Containing L-Histidine

ABSTRACT Purpose An unknown UV 280 nm absorbing peak was observed by SEC for protein stability samples formulated in L-histidine during a stress stability study. Understanding the source would enhance the confidence in the SEC results. We identified the unknown peak, studied the cause, and evaluated...

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Veröffentlicht in:	Pharmaceutical research 2015-08, Vol.32 (8), p.2625-2635
Hauptverfasser:	Wang, Chunlei, Yamniuk, Aaron, Dai, Jun, Chen, Sike, Stetsko, Paul, Ditto, Noah, Zhang, Yingru
Format:	Artikel
Sprache:	eng
Schlagworte:	Biochemistry Biological Products - administration & dosage Biological Products - chemistry Biomedical and Life Sciences Biomedical Engineering and Bioengineering Biomedicine Buffers Chelating Agents - chemistry Chemistry, Pharmaceutical Chromatography Chromatography, High Pressure Liquid Drug Contamination Drug Stability Enzymes Excipients - chemistry Histidine - chemistry Mass Spectrometry Medical Law Pharmaceuticals Pharmacology/Toxicology Pharmacy Proteins Proteins - chemistry Research Paper Spectrophotometry, Ultraviolet Urocanic Acid - chemistry
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