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초록· 키워드
오류제보하기
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.
목차
Abstract
1. Introduction
2. Experimental
3. Results and Discussion
4. Conclusions
References
참고문헌 (26)
참고문헌 신청
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M. I. New and L. S. Levine, Clinical Biochemistry, 14(5), 258-272 (1981).
P. F. Collett-Solberg, Clin Pediatr., 40(1), 1-16 (2001).
A. T. Soliman, M. Omar, M. Al Ali, M. M. Rizk, I. Nasr, and M. AbolMagd, Journal of Tropical Pediatrics, 52(2), 147-148 (2006).
A. Rosler, A. Milewicz, S. Korth-Schlitz, D. Haack, K. Lichtwald, and P. Vecsei, The Journal of Steroid Biochemistry, 17(3), lxxviii (1982).
M. I. New and L. S. Levine, Clinical Biochemistry, 14(5), 258-272 (1981).
P. F. Collett-Solberg, Clin Pediatr., 40(1), 1-16 (2001).
A. T. Soliman, M. Omar, M. Al Ali, M. M. Rizk, I. Nasr, and M. AbolMagd, Journal of Tropical Pediatrics, 52(2), 147-148 (2006).
A. Rosler, A. Milewicz, S. Korth-Schlitz, D. Haack, K. Lichtwald, and P. Vecsei, The Journal of Steroid Biochemistry, 17(3), lxxviii (1982).
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UCI(KEPA) : I410-ECN-0101-2020-433-000094741