Aspects of quality assurance in the determination of 2,4-toluene diisocyanate by HPLC

1990 ◽  
Vol 336 (2) ◽  
pp. 129-131 ◽  
Author(s):  
Edgar Eickeler
Keyword(s):  
Quality Assurance ◽  
Toluene Diisocyanate

scholarly journals Validation and Quality Assurance of Planar Chromatographic Procedures in Pharmaceutical Analysis

2001 ◽  
Vol 84 (4) ◽  
pp. 1265-1276 ◽  
Author(s):  
Katalin Ferenczi-Fodor ◽  
Zoltán Végh ◽  
Anikó Nagy-Turák ◽  
Bernd Renger ◽  
Marco Zeller
Keyword(s):  
Quality Assurance ◽  
Pharmaceutical Analysis ◽  
Control Charts ◽  
Practical Experience ◽  
Standardized Terminology ◽  
Criteria For Evaluation ◽  
Formal Requirements ◽  
Determination Of Impurities ◽  
Validation Experiments

Abstract Within the process of the International Conference on Harmonization (ICH), 2 guidelines were released containing a standardized terminology, a verified model of requirements for the validation of analytical procedures, and some guidance in the practical aspects of conducting validation studies in pharmaceutical analysis. For planar chromatographic procedures, which may be used at different levels either in qualitative identity testing, assays, semiquantitative limit tests, or quantitative determination of impurities, this paper tries to transfer these formal requirements into practical approaches for validation. Basic acceptance criteria for evaluation of validation experiments based on practical experience are proposed. In addition, selected parameters for robustness testing of given procedures and quality assurance of quantitative planar chromatographic testing by control charts is described.

Comparison of denuder and impinger sampling for determination of gaseous toluene diisocyanate (TDI)

2001 ◽  
Vol 371 (1) ◽  
pp. 39-43 ◽  
Author(s):  
Y. Nordqvist ◽  
J. Melin ◽  
U. Nilsson ◽  
R. Johansson ◽  
A. Colmsjo
Keyword(s):  
Toluene Diisocyanate ◽  
Gaseous Toluene
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