Author: Christophe GadoisPublisher:
ISBN:
Category :
Languages : fr
Pages :
Book Description
Méthodologie de validation des méthodes d'analyse en C.L.H.P. et C.P.G.
Author: Christophe GadoisValidation par CLHP de méthodes de prélèvement et d'analyse pour la recherche de traces de principe actif en amont de la fabrication industrielle de formes sèches
Author: Marion StylemansPublisher:
ISBN:
Category :
Languages : fr
Pages : 174
Book Description
Le nettoyage des équipements et des locaux représente une étape à part entière dans le processus de production d’un produit pharmaceutique et la validation de nettoyage des procédés de nettoyage fait partie intégrante de la maîtrise des processus de fabrication. Le but de la validation de méthode de prélèvement par écouvillonnage est de s’assurer que cette méthode permet de récupérer de façon adéquate le résidu contaminant présent sur les surfaces des équipements et/ou des locaux de production. Pour cela, on étudie le taux de recouvrement. Cependant, il est important de valider la méthode analytique, la Chromatographie Liquide à Haute performance, parallèlement à la méthode de prélèvement. La validation d’une méthode d’analyse dans le cadre de la recherche de traces repose sur plusieurs critères : Spécificité, Limites de détection et de quantification, Linéarité, Justesse, Exactitude, Intervalle de dosage, Stabilité de l’analyte. Dans ce document, nous n’avons réalisé qu’une validation partielle. Par conséquent, seuls les critères pouvant être impactés par la mise en place d’une nouvelle méthode de prélèvement avec écouvillons seront étudiés : la spécificité avec le matériel de prélèvement, le profil d’exactitude et la linéarité de la méthode d’analyse, les taux de recouvrement, la stabilité des échantillons.
Principles and Practices of Method Validation
Author: A FajgeljPublisher: Royal Society of Chemistry
ISBN: 1847551750
Category : Science
Languages : en
Pages : 317
Book Description
Principles and Practices of Method Validation is an overview of the most recent approaches used for method validation in cases when a large number of analytes are determined from a single aliquot and where a large number of samples are to be analysed. Much of the content relates to the validation of new methods for pesticide residue analysis in foodstuffs and water but the principles can be applied to other similar fields of analysis. Different chromatographic methods are discussed, including estimation of various effects, eg. matrix-induced effects and the influence of the equipment set-up. The methods used for routine purposes and the validation of analytical data in the research and development environment are documented. The legislation covering the EU-Guidance on residue analytical methods, an extensive review of the existing in-house method validation documentation and guidelines for single-laboratory validation of analytical methods for trace-level concentrations of organic chemicals are also included. With contributions from experts in the field, any practising analyst dealing with method validation will find the examples presented in this book a useful source of technical information.
Validation analytique par Chromatographie Liquide Haute Performance (HPLC)
Author: Sassan GhadimiValidation interne des méthodes d’analyse
Author: Publisher: Ed. Techniques Ingénieur
ISBN:
Category :
Languages : fr
Pages : 23
Book Description
Protocole pour la validation d'une méthode d'analyse en chimie
Author: Place de la validation de méthodes analytiques dans le développement de nouveaux médicaments
Author: Mathilde GrolleauMéthodes physico-chimiques d'analyse
Author: Advances in Solid State Fermentation
Author: S. RoussosPublisher: Springer Science & Business Media
ISBN: 9401706611
Category : Technology & Engineering
Languages : en
Pages : 641
Book Description
G.HAINNAUX Departement Milieu et Activites Agricoles, Centre ORSTOM, 911 Avenue d' Agropolis, B.P. 5045, 34032 Montpellier Cedex , France. Solid state fermentation, popularly abbreviated as SSF, is currently investigated by many groups throughout the world. The study of this technique was largely neglected in the past in European and Western countries and there is now a high demand for SSF, meaning in food, environment, agricultural, phannaceutical and many other biotechnological applications. It gives me satisfaction to note that the importance of this technique was realised at my department way back in 1975 since then, our team has put concentrated efforts on developing this technique. xvii Foreword Advances in Solid State Fermentation Foreword M. PUYGRENIER Agropolis Valorisation, Avenue d' Agropolis, 34394 Montpellier Cedex 5, France. On the name of the Scientific Community, I would like to express the wish that this International Symposium on SSF should be successful. Solid State Fermentation is part of biotechnology research. It consists on seeding solid culture medium with bacteria or fungi (filamentous or higher) and on producing, in this medium (solid components and exudates) metabolites and high value products. In fact, this process is very old. In older industries such the food and agricultural, this technique has been extensively used. An example of this is the production of pork sausages and Roquefort cheese. Pharmaceutical industry could make extensive use of SSF in the production of secondary metabolites of many kinds and development in this direction is soon expected.
Handbook of GC-MS
Author: Hans-Joachim HubschmannPublisher: John Wiley & Sons
ISBN: 3527334742
Category : Science
Languages : en
Pages : 884
Book Description
The only comprehensive reference on this popular and rapidly developing technique provides a detailed overview, ranging from fundamentals to applications, including a section on the evaluation of GC-MS analyses. As such, it covers all aspects, including the theory and principles, as well as a broad range of real-life examples taken from laboratories in environmental, food, pharmaceutical and clinical analysis. It also features a glossary of approximately 300 terms and a substance index that facilitates finding a specific application. The first two editions were very well received, making this handbook a must-have in all analytical laboratories using GC-MS.