Validation of HPLC method used for control of cleaning procedure during the pharmaceutical substance manufacturing

被引：0
|
作者：
Baran, Piotr A.
Bielejewska, Anna
Glice, Magdalena M.
Beczkowicz, Hanna
Maruszak, Wioleta
Kosmacinska, Bozenna
Golebiewski, Piotr
机构：
[1] Inst Farmaceut, PL-01793 Warsaw, Poland
[2] Inst Chem Fizycznej, Warsaw, Poland
来源：
PRZEMYSL CHEMICZNY | 2007年 / 86卷 / 08期
关键词：
D O I：
暂无
中图分类号：
O6 [化学];
学科分类号：
0703 ;
摘要：
The high-performance liq. chromatog. used for detn. of residual active substances during cleaning apps. for pharmaceutical prodn. was optimized and validated. The specific nature, measurement precision, linearity, detactability range and limits, accuracy and stability of solns. were taken into consideration. All quality requirements were met for prodn. of acyclovir, N-acetyltyrosine and sulfadimetoxine.
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页码：747 / 750
页数：4
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