TEST PROCEDURE VALIDATION FOR THE TLC ASSAY OF A DEGRADATION PRODUCT IN A PHARMACEUTICAL FORMULATION

被引：23

作者：

SUN, SW

FABRE, H

MAILLOLS, H

机构：

[1] FAC PHARM MONTPELLIER,CHIM ANALYT LAB,F-34060 MONTPELLIER,FRANCE

[2] FAC PHARM MONTPELLIER,TECH PHARMACEUT IND LAB,F-34060 MONTPELLIER,FRANCE

来源：

JOURNAL OF LIQUID CHROMATOGRAPHY | 1994年 / 17卷 / 11期

关键词：

D O I：

10.1080/10826079408013496

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

An experimental and statistical approach for validating the TLC assay of a degradation product in a pharmaceutical formulation is given. This validation approach is intended to take into account the main particular aspects of the technique.

引用

页码：2495 / 2509

页数：15

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