ABSTRACT
Objective To modify the purified water analysis methods in the Chinese Pharmacopoeia (Vol .Ⅱ ,Edition 2010) ,and mainly focus on the pH value determination ,analysis of nitrate and nitrite ,and the inspection of microorganism . Methods The usage of regents and colorimetric tubes in the analysis of nitrate and nitrite were inquired ,the feasibility of plat-ing culture used in the inspection of microorganism were proposed ,and the suggestion of using more instrumental analysis in-stead of titrimetric analysis in the purified water inspection wasraised .Results The choice of colormetric apparatus and the precision of the regents were explicit .The plating method was better in convenience and reliability than membrane-filter proce-dure during the microorganism inspection .Instrumental analysis is the trend of purified water inspection and deserved to be rec-ommended .Conclusion Based on our own and others′studies ,the methods of impurity analysis are improved ,which might be accepted in the revision of Chinese Pharmacopoeia in future .
ABSTRACT
INTRODUCCIÓN: la producción de medicamentos se rige por estrictas normas internacionales que garantizan la reproducibilidad y consistencia de los resultados obtenidos. La calificación de los instrumentos utilizados en los procesos productivos, así como en la caracterización de los productos y su control de calidad, constituye un requisito previo a la validación de cualquier técnica analítica que haga uso de estos. Una de las técnicas instrumentales utilizada en la industria biotecnológica es la cromatografía de gases. OBJETIVO: desarrollar y ejecutar un protocolo que permita la calificación de un cromatógrafo de gases Agilent Technologies 7890A. MÉTODOS: se empleó un patrón de cafeína pura para análisis y se utilizó una columna HP-5 de 30 m x 0,32 mm d.i. y 0,33 µm espesor de película, en un cromatógrafo de gases acoplado a un detector de ionización de llama. Los diferentes módulos involucrados en el análisis (inyector, columna, horno y detector) se evaluaron a través de un diseño experimental que calcula varios parámetros. RESULTADOS: se obtuvieron pruebas documentadas que demuestran que cada uno de los parámetros estudiados (linealidad del inyector, precisión del inyector, arrastre del inyector, precisión del flujo, exactitud del flujo, linealidad del detector, exactitud del detector, ruido del detector, deriva del detector) cumple con los criterios de aceptación establecidos. CONCLUSIONES: el protocolo desarrollado permite la calificación de un cromatógrafo de gases Agilent Technologies 7890A y puede ser extrapolado a otros modelos(AU)
INTRODUCTION: the drug manufacture is governed by strict international standards that guarantee reproducibility and consistency of results. The qualification of the instruments used in the productive processes, as well as in the characterization of products and their quality control are prerequisites to the validation of any analytical technique using them. One of the instrumental techniques used in the biotechnical industry is Gas Chromatography. OBJECTIVE: to develop and to perform a protocol that allows the qualification of an Agilent Technologies 7890A Gas Chromatograph. METHODS: a standard of pure caffeine was used for analysis in addition to a HP-5 30 m x 0,32 mm d.i. and 0,33 µm thick film column was used in a Gas Chromatograph coupled with a Flame Ionization Detector. For the testing of the different modules involved in the analysis (injector, column, oven and detector), an experimental design was made to estimate several parameters. RESULTS: the obtained documented tests proved that each of the studied parameters (injector linearity, injector precision, injector dragging, flow precision, flow accuracy, detector linearity, detector accuracy, detector noise and detector drift) met the set acceptance criteria. CONCLUSIONS: the final protocol allows the qualification of an Agilent Technologies 7890A Gas Chromatograph and it can be extrapolated to other models(AU)
Subject(s)
Humans , Quality Control , Gas Chromatographers/methods , Production of Products , Validation StudyABSTRACT
Some problems, such as the differences of intelligence and knowledge basis among the students, ambiguity of teaching goal and lack of proper textbooks for instrumental analysis as well as "double-teacher", should be solved urgently. The authors try to find out some solutions to them.