This site uses cookies.
Some of these cookies are essential to the operation of the site,
while others help to improve your experience by providing insights into how the site is being used.
For more information, please see the ProZ.com privacy policy.
Freelance translator and/or interpreter, Verified member
Data security
This person has a SecurePRO™ card. Because this person is not a ProZ.com Plus subscriber, to view his or her SecurePRO™ card you must be a ProZ.com Business member or Plus subscriber.
Affiliations
This person is not affiliated with any business or Blue Board record at ProZ.com.
Services
Translation, Interpreting, Editing/proofreading, Website localization, Transcription, Training
English to Spanish: Control of drug susbstance General field: Medical Detailed field: Medical: Pharmaceuticals
Source text - English 3.2.S.4 CONTROL OF DRUG SUBSTANCE
TABLE OF CONTENTS
3.2.S.4.3 Validation of Analytical Procedures 3
5. Analysis of Residual Solvents in Linaclotide by Gas
Chromatography 3
5.1 Summary 3
5.2 Method Overview 3
5.3 Validation Results 4
5.3.1 Data Summary 4
5.3.2 Specificity 8
5.3.3 Precision 9
5.3.4 Linearity 14
5.3.5 Accuracy 17
5.3.6 Limit of Quantitation and Limit of Detection 17
5.3.7 Ruggedness 18
5.3.8 Solution Stability 19
5.3.9 System Suitability 20
5.4 Conclusions 21
LIST OF TABLES
Table 1 GC Conditions Used in the Determination of Residual
Solvents 4
Table 2 Summary of Validation Results — General Method
Parameters 5
Table 3 Summary of Validation Results for Acetonitrile, 2-Propanol
and Dimethyl Sulfoxide 6
Table 4 Summary of Validation Results for DCM, MTBE and DMF 7
Table 5 Retention Times for Residual Solvents 9
Table 6 System Precision 11
Table 7 Intermediate Precision 12
Table 8 Limits of Quantitation and Detection 18
Table 9 Evaluation of Robustness 19
Table 10 Stability of the Working Standard Solution 20
Translation - Spanish .2.S.4 Control del principio activo
Índice
3.2.S.4.3 Validación de procedimientos analíticos.....................3
5. Análisis de solventes residuales en la linaclotida por cromatografía de gases...............................................................3
5.1 Resumen..................................................................3
5.2 Visión general del método...........................................3
5.3 Resultados de validación…...........................................4
5.3.1 Resumen de datos...............................................4
5.3.2 Especificidad.......................................................8
5.3.3 Precisión.............................................................9
5.3.4 Linealidad.........................................................14
5.3.5 Exactitud..........................................................17
5.3.6 Límites de cuantificación y detección................17
5.3.7 Robustez...........................................................18
5.3.8 Estabilidad de la solución....................................19
5.3.9 Idoneidad del sistema.........................................20
5.4 Conclusiones........................................................21
Lista de Tablas
Tabla 1 Condiciones de la cromatografía de gases utilizada para determinar los solventes residuales..............................4
Tabla 2 Resumen de resultados de validación - Metodología general y Parámetros.................................................5
Tabla 3 Resumen de resultados de validación para el acetonitrilo, el 2-propanol y el dimetil-sulfóxido (DMSO)...................6
Tabla 4 Resumen de resultados de validación para el diclorometano (DCM), metil tert-butyl éter (MTBE) y N,N-Dimetilformamida (DMF)......................................7
Tabla 5 Tiempos de retención para solventes residuales.............9
Tabla 6 Precisión del sistema................................................11
Tabla 7 Precisión intermedia.................................................12
Tabla 8 Límites de cuantificación y detección...........................18
Tabla 9 Evaluación de la robustez..........................................19
Tabla 10 Estabilidad de la solución estándar de trabajo..............20
Tabla 11 Parámetros de idoneidad del sistema..........................21
Tabla 12 Repetibilidad - Acetonitrilo, 2-propanol y Dimetil-sulfóxido (DMSO)..................................................................22
Tabla 13 Repetibilidad - Diclorometano (DCM), Metil tert-butyl éter (MTBE) y N,N-Dimetilformamida (DMF).......................23
Tabla 14 Resultados de linealidad - Acetonitrilo.........................24
Tabla 15 Resultados de linealidad - 2-Propanol..........................25
Tabla 16 Resultados de linealidad - Dimetil-sulfóxido (DMSO).....26
Tabla 17 Resultados de linealidad - Diclorometano (DCM)...........27
More
Less
Translation education
Master's degree - University of La Laguna - Master in Conference interpreting
Experience
Years of experience: 15. Registered at ProZ.com: Oct 2013. Became a member: Oct 2013.
Arabic to Spanish (Universidad Autónoma de Madrid (Facultad de Filosofía y Letras)) Arabic to Spanish (Morocco - Dar loughat) English to Spanish (ULL - MIC) French to Spanish (Ministerio de Asuntos Exteriores) French to Spanish (Universidad Autónoma de Madrid (Facultad de Filosofía y Letras))
Spanish to French (Ministerio de Asuntos Exteriores)
More
Less
Memberships
N/A
Software
Adobe Acrobat, Microsoft Excel, Microsoft Word, Trados Studio
Member since Oct '13
Expertise