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Direct Determination of ECD in ECD Kit: A Solid Sample Quantitation Method for Active Pharmaceutical Ingredient in Drug Product

Technetium-99m ethyl cysteinate dimer (Tc-99m-ECD) is an essential imaging agent used in evaluating the regional cerebral blood flow in patients with cerebrovascular diseases. Determination of active pharmaceutical ingredient, that is, L-Cysteine, N, N′-1,2-ethanediylbis-, diethyl ester, dihydrochlo...

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Autores principales: Chao, Ming-Yu, Liu, Kung-Tien, Hsia, Yi-Chih, Liao, Mei-Hsiu, Shen, Lie-Hang
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Hindawi Publishing Corporation 2011
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3114541/
https://www.ncbi.nlm.nih.gov/pubmed/21687539
http://dx.doi.org/10.1155/2011/196238
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author Chao, Ming-Yu
Liu, Kung-Tien
Hsia, Yi-Chih
Liao, Mei-Hsiu
Shen, Lie-Hang
author_facet Chao, Ming-Yu
Liu, Kung-Tien
Hsia, Yi-Chih
Liao, Mei-Hsiu
Shen, Lie-Hang
author_sort Chao, Ming-Yu
collection PubMed
description Technetium-99m ethyl cysteinate dimer (Tc-99m-ECD) is an essential imaging agent used in evaluating the regional cerebral blood flow in patients with cerebrovascular diseases. Determination of active pharmaceutical ingredient, that is, L-Cysteine, N, N′-1,2-ethanediylbis-, diethyl ester, dihydrochloride (ECD) in ECD Kit is a relevant requirement for the pharmaceutical quality control in processes of mass fabrication. We here presented a direct solid sample determination method of ECD in ECD Kit without sample dissolution to avoid the rapid degradation of ECD. An elemental analyzer equipped with a nondispersive infrared detector and a calibration curve of coal standard was used for the quantitation of sulfur in ECD Kit. No significant matrix effect was found. The peak area of coal standard against the amount of sulfur was linear over the range of 0.03–0.10 mg, with a correlation coefficient (r) of 0.9993. Method validation parameters were achieved to demonstrate the potential of this method.
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spelling pubmed-31145412011-06-17 Direct Determination of ECD in ECD Kit: A Solid Sample Quantitation Method for Active Pharmaceutical Ingredient in Drug Product Chao, Ming-Yu Liu, Kung-Tien Hsia, Yi-Chih Liao, Mei-Hsiu Shen, Lie-Hang J Biomed Biotechnol Research Article Technetium-99m ethyl cysteinate dimer (Tc-99m-ECD) is an essential imaging agent used in evaluating the regional cerebral blood flow in patients with cerebrovascular diseases. Determination of active pharmaceutical ingredient, that is, L-Cysteine, N, N′-1,2-ethanediylbis-, diethyl ester, dihydrochloride (ECD) in ECD Kit is a relevant requirement for the pharmaceutical quality control in processes of mass fabrication. We here presented a direct solid sample determination method of ECD in ECD Kit without sample dissolution to avoid the rapid degradation of ECD. An elemental analyzer equipped with a nondispersive infrared detector and a calibration curve of coal standard was used for the quantitation of sulfur in ECD Kit. No significant matrix effect was found. The peak area of coal standard against the amount of sulfur was linear over the range of 0.03–0.10 mg, with a correlation coefficient (r) of 0.9993. Method validation parameters were achieved to demonstrate the potential of this method. Hindawi Publishing Corporation 2011 2011-06-09 /pmc/articles/PMC3114541/ /pubmed/21687539 http://dx.doi.org/10.1155/2011/196238 Text en Copyright © 2011 Ming-Yu Chao et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research Article
Chao, Ming-Yu
Liu, Kung-Tien
Hsia, Yi-Chih
Liao, Mei-Hsiu
Shen, Lie-Hang
Direct Determination of ECD in ECD Kit: A Solid Sample Quantitation Method for Active Pharmaceutical Ingredient in Drug Product
title Direct Determination of ECD in ECD Kit: A Solid Sample Quantitation Method for Active Pharmaceutical Ingredient in Drug Product
title_full Direct Determination of ECD in ECD Kit: A Solid Sample Quantitation Method for Active Pharmaceutical Ingredient in Drug Product
title_fullStr Direct Determination of ECD in ECD Kit: A Solid Sample Quantitation Method for Active Pharmaceutical Ingredient in Drug Product
title_full_unstemmed Direct Determination of ECD in ECD Kit: A Solid Sample Quantitation Method for Active Pharmaceutical Ingredient in Drug Product
title_short Direct Determination of ECD in ECD Kit: A Solid Sample Quantitation Method for Active Pharmaceutical Ingredient in Drug Product
title_sort direct determination of ecd in ecd kit: a solid sample quantitation method for active pharmaceutical ingredient in drug product
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3114541/
https://www.ncbi.nlm.nih.gov/pubmed/21687539
http://dx.doi.org/10.1155/2011/196238
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