Screening of heparin API by near infrared reflectance and Raman spectroscopy

Journal of Pharmaceutical Sciences
John A SpencerBenjamin J Westenberger

Abstract

Near infrared (NIR) reflectance and laser Raman spectra for a set of 69 heparin powder samples obtained from several foreign and domestic suppliers were measured. Both the NIR and Raman spectra of individual heparin API powder samples were correlated with sample compositions determined from response corrected relative peak areas of the capillary electropherograms of the samples using a partial least squares (PLS) regression model. Twenty-eight sample spectra were used to develop PLS models for the three major sample components; heparin, oversulfated chondroitin sulfate (OSCS) and glycosaminoglycans (GAGs). The PLS models were then used to successfully predict the compositions of 41 additional heparin samples. The success of these rapid, nondestructive technologies to identify contamination of heparin with OSCS demonstrates the potential of spectroscopy and chemometrics for screening of processed raw materials. These technologies are meant for screening purposes and not meant to replace either of the methods (capillary electrophoresis and NMR) currently required by USP and FDA.

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Citations

Sep 4, 2010·Analytical and Bioanalytical Chemistry·Szabolcs BeniCynthia K Larive
Oct 7, 2009·Proceedings of the National Academy of Sciences of the United States of America·Marco GuerriniRam Sasisekharan
Mar 19, 2013·Spectrochimica Acta. Part A, Molecular and Biomolecular Spectroscopy·Hengchang ZangFengshan Wang
Sep 21, 2010·Analytical Biochemistry·Zhenling LiuRobert J Linhardt
Dec 29, 2009·Journal of Pharmaceutical and Biomedical Analysis·Chunxiao SunLinyan Sui
Feb 11, 2015·Chemical Communications : Chem Comm·Megan TwomeyJoong Ho Moon
Feb 4, 2011·Clinical and Applied Thrombosis/hemostasis : Official Journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis·Eduardo RamacciottiJawed Fareed
Jun 25, 2020·Molecules : a Journal of Synthetic Chemistry and Natural Product Chemistry·María Del Pilar Rodriguez-TorresLaura Susana Acosta-Torres
Jun 10, 2016·Nature Biotechnology·Anita Y SzajekAli Al-Hakim
Sep 29, 2019·Medicina·Anthony DevlinMark Skidmore
Dec 8, 2020·Journal of Pharmaceutical and Biomedical Analysis·Natalia A BurmistrovaYulia B Monakhova
Oct 17, 2013·Journal of the American Chemical Society·Mausam KalitaBalagurunathan Kuberan

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