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Purity assignment of 17α-hydroxyprogesterone by mass balance method to establish traceability in measurement
Analytical Science and Technology / Analytical Science and Technology, (P)1225-0163; (E)2288-8985
2019, v.32 no.6, pp.225-232
https://doi.org/10.5806/AST.2019.32.6.225
(Center for Bioanalysis, Division of Chemical and Medical Metrology, Korea Research Institute of Standards and Science)
(Cultural Heritage Conservation Science Center, National Research Institute of Cultural Heritage)
(Cultural Heritage Conservation Science Center, National Research Institute of Cultural Heritage)
Hwa,
S.
L.
, &
Su,
J.
P.
(2019). Purity assignment of 17α-hydroxyprogesterone by mass balance method to establish traceability in measurement. Analytical Science and Technology, 32(6), 225-232, https://doi.org/10.5806/AST.2019.32.6.225
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Abstract
Traceability establishment in chemical measurements is a like a linkage established through an unbroken chain from the measured results to the international system (SI) of units. The primary process for traceability establishment is the purity assignment of a target material to be measured. In this study, we studied the purity assignment of 17α-hydroxyprogesterone (17-OHP). The presence of 17-OHP is indicative of congenital adrenal hyperplasia (CAH) and it builds up due to the deficiency of 21-hydroxylase and 11β-hydroxylase enzyme in the human blood. The purity assignment of 17-OHP was performed by the mass balance method, in which the impurities are categorized into four classes: total related structural impurities, water, residual organic solvents, and nonvolatiles/inorganics. The total related structural impurities were characterized by HPLC-UV; water content was determined by Karl-Fisher coulometer; and the total residual solvents and nonvolatiles/inorganics were determined by TGA. The purity of 17-OHP from a commercial manufacturer was calculated as 993.30 mg/g, and the expanded uncertainty was 0.58 mg/g. The proposed method was validated by uncertainty evaluation and comparing with the actual value of purity.
- keywords
- 17-OHP, purity, traceability, mass balance method, CAH
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