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; Masami Nakai; Masato Kazusaki

doi:doi:10.11648/j.sjac.20200801.11

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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, Masami Nakai, Masato Kazusaki

Published in Science Journal of Analytical Chemistry (Volume 8, Issue 1)

Received: 25 December 2019 Accepted: 7 January 2020 Published: 30 January 2020

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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.

Published in	Science Journal of Analytical Chemistry (Volume 8, Issue 1)
DOI	10.11648/j.sjac.20200801.11
Page(s)	1-4
Creative Commons	This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.
Copyright	Copyright © The Author(s), 2020. Published by Science Publishing Group

Keywords

ICP-MS, Oligonucleotide, Validation, Sampling, Manufacture, Cleanliness

References

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[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.
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APA Style

Daisuke Furukawa, Masami Nakai, Masato Kazusaki. (2020). 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, 8(1), 1-4. https://doi.org/10.11648/j.sjac.20200801.11

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ACS Style

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. Sci. J. Anal. Chem. 2020, 8(1), 1-4. doi: 10.11648/j.sjac.20200801.11

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AMA Style

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. Sci J Anal Chem. 2020;8(1):1-4. doi: 10.11648/j.sjac.20200801.11

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@article{10.11648/j.sjac.20200801.11,
  author = {Daisuke Furukawa and Masami Nakai and Masato Kazusaki},
  title = {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},
  journal = {Science Journal of Analytical Chemistry},
  volume = {8},
  number = {1},
  pages = {1-4},
  doi = {10.11648/j.sjac.20200801.11},
  url = {https://doi.org/10.11648/j.sjac.20200801.11},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.sjac.20200801.11},
  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.},
 year = {2020}
}

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TY  - JOUR
T1  - 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
AU  - Daisuke Furukawa
AU  - Masami Nakai
AU  - Masato Kazusaki
Y1  - 2020/01/30
PY  - 2020
N1  - https://doi.org/10.11648/j.sjac.20200801.11
DO  - 10.11648/j.sjac.20200801.11
T2  - Science Journal of Analytical Chemistry
JF  - Science Journal of Analytical Chemistry
JO  - Science Journal of Analytical Chemistry
SP  - 1
EP  - 4
PB  - Science Publishing Group
SN  - 2376-8053
UR  - https://doi.org/10.11648/j.sjac.20200801.11
AB  - 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.
VL  - 8
IS  - 1
ER  -

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Author Information

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

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APA Style

Daisuke Furukawa, Masami Nakai, Masato Kazusaki. (2020). 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, 8(1), 1-4. https://doi.org/10.11648/j.sjac.20200801.11

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ACS Style

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. Sci. J. Anal. Chem. 2020, 8(1), 1-4. doi: 10.11648/j.sjac.20200801.11

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AMA Style

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. Sci J Anal Chem. 2020;8(1):1-4. doi: 10.11648/j.sjac.20200801.11

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@article{10.11648/j.sjac.20200801.11,
  author = {Daisuke Furukawa and Masami Nakai and Masato Kazusaki},
  title = {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},
  journal = {Science Journal of Analytical Chemistry},
  volume = {8},
  number = {1},
  pages = {1-4},
  doi = {10.11648/j.sjac.20200801.11},
  url = {https://doi.org/10.11648/j.sjac.20200801.11},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.sjac.20200801.11},
  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.},
 year = {2020}
}

Copy | Download

TY  - JOUR
T1  - 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
AU  - Daisuke Furukawa
AU  - Masami Nakai
AU  - Masato Kazusaki
Y1  - 2020/01/30
PY  - 2020
N1  - https://doi.org/10.11648/j.sjac.20200801.11
DO  - 10.11648/j.sjac.20200801.11
T2  - Science Journal of Analytical Chemistry
JF  - Science Journal of Analytical Chemistry
JO  - Science Journal of Analytical Chemistry
SP  - 1
EP  - 4
PB  - Science Publishing Group
SN  - 2376-8053
UR  - https://doi.org/10.11648/j.sjac.20200801.11
AB  - 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.
VL  - 8
IS  - 1
ER  -

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