1989
DOI: 10.1007/bf02290388
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Requirements and tests for HPLC apparatus and methods in pharmaceutical quality control

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Cited by 13 publications
(2 citation statements)
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“…Therefore, system suitability tests have been described, which permit the control of the correct Presented at the 21 st ISC held in Stuttgart, Germany, 15th-20 th September, 1996 functioning of the whole system. A convenient way for routine system validation is to use a chromatographic column and a mixture of aromatic hydrocarbons [1,2]. This tests complete systems, especially the repeatability of injection and the short term flow accuracy of the eluent delivery system.…”
Section: Introductionmentioning
confidence: 99%
“…Therefore, system suitability tests have been described, which permit the control of the correct Presented at the 21 st ISC held in Stuttgart, Germany, 15th-20 th September, 1996 functioning of the whole system. A convenient way for routine system validation is to use a chromatographic column and a mixture of aromatic hydrocarbons [1,2]. This tests complete systems, especially the repeatability of injection and the short term flow accuracy of the eluent delivery system.…”
Section: Introductionmentioning
confidence: 99%
“…The performance quality of the instrument can significantly affect the analytical results during method development, validation and analysis of samples. General benchmarks for the verification of error‐free performance of chromatography instrumentation are provided in the pharmacopoeia and other regulatory guidelines (Analytical instrument qualification effective <1058>, ; Bansal et al, ; Huber, ; Maldener, ; Quevauviller, ). However, analytical instrument qualification testing is a very time‐consuming process, making it difficult to carry out on a routine basis.…”
Section: Hazards In Bioanalytical Methods Developmentmentioning
confidence: 99%