title: Direct determination of ECD in ECD Kit: a solid sample quantitation method for active pharmaceutical ingredient in drug product.
abstract: 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.
authors.affiliation: Chemical Analysis Division, Institute of Nuclear Energy Research, Taoyuan, Taiwan.
authors.forename: Ming-Yu
authors.initials: MY
authors.lastname: Chao
authors.forename: Kung-Tien
authors.initials: KT
authors.lastname: Liu
authors.forename: Yi-Chih
authors.initials: YC
authors.lastname: Hsia
authors.forename: Mei-Hsiu
authors.initials: MH
authors.lastname: Liao
authors.forename: Lie-Hang
authors.initials: LH
authors.lastname: Shen
mesh_terms: D002560:Cerebrovascular Circulation; D002561:Cerebrovascular Disorders / Q000000981:diagnostic imaging; D002623:Chemistry Techniques, Analytical; D003545:Cysteine / Q000031:analogs & derivatives* / Q000737:chemistry / Q000592:standards; D003553:Cystine / Q000031:analogs & derivatives* / Q000032:analysis; D004355:Drug Stability; D006801:Humans; D015609:Organotechnetium Compounds / Q000737:chemistry / Q000592:standards*; D011786:Quality Control; D011877:Radionuclide Imaging; D019275:Radiopharmaceuticals / Q000737:chemistry / Q000592:standards*; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D013455:Sulfur / Q000032:analysis*
chemical_list: D015609:Organotechnetium Compounds; D019275:Radiopharmaceuticals; D011933:Reagent Kits, Diagnostic; C541351:ethyl cysteinate dimer; D003553:Cystine; D013455:Sulfur; C059659:technetium Tc 99m bicisate; D003545:Cysteine