Volume 8, Issue 1, March 2020, Page: 1-4
An Analytical Procedure by the Inductively Coupled Plasma Mass Spectrometry (ICP-MS) for the Quantitation of Total Phosphorus Content on the Surface of the Manufacturing Equipment for Oligonucleotides
Daisuke Furukawa, Quality Assurance Office Health & Crop Science Sector, Sumitomo Chemical Co., Ltd., Osaka, Japan
Masami Nakai, Quality Assurance Office Health & Crop Science Sector, Sumitomo Chemical Co., Ltd., Osaka, Japan
Masato Kazusaki, Quality Assurance Office Health & Crop Science Sector, Sumitomo Chemical Co., Ltd., Osaka, Japan
Received: Dec. 25, 2019;       Accepted: Jan. 7, 2020;       Published: Jan. 30, 2020
DOI: 10.11648/j.sjac.20200801.11      View  124      Downloads  88
Abstract
An analytical procedure by the inductively coupled plasma mass spectrometry (ICP-MS) is provided to quantitate the remaining phosphorus amount on the surface of the manufacturing equipment for the oligonucleotide active pharmaceutical ingredient (API). In this analytical procedure, the sample solutions obtained from the rinse sampling and direct surface sampling methods are directly injected into the ICP-MS equipment without the inspissation of the extraction liquid. The limit of quantitation for phosphorous was 0.02 µg/mL. Quantitation of phosphorous was achieved over a linear range of 0.02 to 0.8 µg/mL. Analytical validation was carried out to prove that this analytical procedure is appropriate and effective to monitor the cleanliness of the manufacturing equipment after the oligonucleotide API manufacturing and the following cleaning of the equipment. Calibration curve originally passed through the origin with correlation coefficient of 0.999. The precision through the rinse sampling method was within ±10%. The satisfactory accuracy for the rinse sampling method was proven from the assessment of linearity and precision. The precision and accuracy of the analytical procedure were both within ±10% for the direct surface sampling method. The described analytical procedure by ICP-MS following the two types of the sampling procedures can easily be applied to the routine analysis for the verification of the cleanliness of the manufacturing equipment for oligonucleotide API.
Keywords
ICP-MS, Oligonucleotide, Validation, Sampling, Manufacture, Cleanliness
To cite this article
Daisuke Furukawa, Masami Nakai, Masato Kazusaki, An Analytical Procedure by the Inductively Coupled Plasma Mass Spectrometry (ICP-MS) for the Quantitation of Total Phosphorus Content on the Surface of the Manufacturing Equipment for Oligonucleotides, Science Journal of Analytical Chemistry. Vol. 8, No. 1, 2020, pp. 1-4. doi: 10.11648/j.sjac.20200801.11
Copyright
Copyright © 2020 Authors retain the copyright of this article.
This article is an open access article distributed under the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Reference
[1]
S. Crooke, Antisense Nucleic Acid Drug Dev. 8 (2) (1998) 133.
[2]
S. Crooke, Vitravene – another piece in the mosaic, Antisense Nucleic Acid Drug Dev. 8 (4) (1998) (vii-viii).
[3]
T. Abe, T. Mizuta, T. Hatta, N. Miyano-Kurosaki, M. Fujiwara, K. Takai, S. Shigeta, T. Yokota, H. Takaku, Antisense therapy of influenza, Eur. J. Pharm. Sci. 13 (2001) 61–69.
[4]
N. Dias, C. A. Stein, Antisense oligonucleotides: basic concepts and mechanisms, Mol. Cancer Ther. 1 (2002) 347–355.
[5]
N. M. Dean, F. Bennett, Antisense oligonucleotide-based therapeutics for cancer, Oncogene 22 (2003) 9087–9096.
[6]
C. Mello, D. Conte, Revealing the world of RNA interference, Nature 431 (2004) 338–342.
[7]
D. P. Bartel, MicroRNAs: genomics, biogenesis, mechanism, and function, Cell 116 (2004) 281–297.
[8]
S. Doggrell, Expert Opin. Pharmacother. 6 (8) (2005) 1421.
[9]
S. Doggrell, Pegaptanib: the first antiangiogenic agent approved for neovascular macular degeneration, Expert Opin. Pharmacother. 6 (8) (2005) 1421–1423.
[10]
S. T. Crooke, An overview of progress in antisense therapeutics, Antisense Nucleic Acid Drug Dev. 8 (2) (2009) 115–122.
[11]
A. C. McGinnis, B. Chen, M. G. Bartlett, Chromatographic methods for the determination of therapeutic Oligonucleotides, J. Chromatogr. B 883 (2012) 76–94.
[12]
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, GOOD MANUFACTURING PRACTICE GUIDE FOR ACTIVE PHARMACEUTICAL INGREDIENTS Q7, 2000. https://www.pmda.go.jp/files/00.026709.pdf.
[13]
C Diane Beauchemin, Inductively Coupled Plasma Mass spectroscopy, Anal. Chem., 2010, 82, 12, 4786-4810.
[14]
D R. S. Houk., Mass spectrometry of inductively coupled plasmas, Anal. Chem., 1986, 58, 1, 97A-105A.
[15]
E Scott C Wilschefski, Matthew R Baxter, Inductively Coupled Plasma Mass Spectrometry: Introduction to Analytical Aspects, Clin Biochem Rev., 2019 Aug; 40 (3): 115–133.
[16]
Jeffrey R. Bacon, Jeffrey S. Crain, Luc Van Vaeck and John G. Williams, Atomic mass spectrometry, Journal of Analytical Atomic Spectrometry, 14 (10), 1633-1659.
[17]
Pharmacopoeia of the United States of America (USP).
[18]
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, VALIDATION OF ANALYTICAL PROCEDURES: TEXT AND METHODOLOGY Q2 (R1), 2005. https://www.pmda.go.jp/files/00.026867.pdf.
[19]
D. Pro¨ frock, P. Leonhard, A. Prange. ‘‘Determination of phosphorus in phosphorylated deoxyribonucleotides using capillary electrophoresis and high performance liquid chromatography hyphenated to inductively coupled plasma mass spectrometry with an octopole reaction cell’’. J. Anal. At. Spectrom. 2003. 18 (7): 708-713.
[20]
M. Edler, N. Jakubowski, M. Linscheid. ‘‘Quantitative determination of melphalan DNA adducts using HPLC – inductively coupled mass spectrometry’’. J. Mass. Spectrom. 2006. 41 (4): 507-516.
[21]
D. G. Sar, L. Aguado, M. M. Bayon, M. A. Comendador, E. B. Gonzalez, A. Sanz-Medel, L. M. Sierra. ‘‘Relationships between cisplatin-induced adducts and DNA strandbreaks, mutation and recombination in vivo in somatic cells of Drosophila melanogaster, under different conditions of nucleotide excision repair’’. Mutation Research-Genetic Toxicology and Environmental Mutagenesis. 2012. 741 (1-2): 81-88.
[22]
L. L. Fernandez, M. Montes-Bayon, E. B. Gonzalez, L. M. Sierra, A. Sanz-Medel, J. Bettmer. ‘‘Initial studies on quantitative DNA induced oxidation by gel electrophoresis (GE)-ICP-MS’’. J. Anal. At. Spectrom. 2011. 26 (1): 195-200.
[23]
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, ASSESSMENT AND CONTROL OF DNA REACTIVE (MUTAGENIC) IMPURITIES IN PHARMACEUTICALS TO LIMIT POTENTIAL CARCINOGENIC RISK M7 (R1), 2017. http://www.pmda.go.jp/files/000218750.pdf.
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