Validation of GC method for quantitative determination of residual 2-(2-chloroethoxy)ethanol (CEE) and N-methyl-2-pyrrolidinone (NMP) in pharmaceutical active substance.
نویسندگان
چکیده
The gas chromatography method with direct injection for quantitative determination of residual nonvolatile solvents such as 2-(2-chloroethoxy)ethanol (CEE) and N-methyl-2-pyrrolidinone (NMP) in quetiapine--the pharmaceutical active substance has been validated. Validation was performed according to the requirement of ICH validation guidelines Q2A and Q2B. Specificity, precision, accuracy, linearity, limits of detection and quantitation and robustness were determined and excellent results were obtained.
منابع مشابه
Investigation of Behavior of Forced Degradation of Lidocaine HCl by NMR Spectroscopy and GC-FID Methods: Validation of GC-FID Method for Determination of Related Substance in Pharmaceutical Formulations
The forced degradation study of lidocaine HCl was carried out according to the ICH guideline Q1A (R2). The degradation conditions were assessed to be hydrolysis, oxidation, photolysis and dry heat during 24 h, 48 h and 72 h and then the samples were investigated by GC-FID method and nuclear magnetic resonance (NMR) spectroscopy. According to these results, the degradation products were not o...
متن کاملInvestigation of Behavior of Forced Degradation of Lidocaine HCl by NMR Spectroscopy and GC-FID Methods: Validation of GC-FID Method for Determination of Related Substance in Pharmaceutical Formulations
The forced degradation study of lidocaine HCl was carried out according to the ICH guideline Q1A (R2). The degradation conditions were assessed to be hydrolysis, oxidation, photolysis and dry heat during 24 h, 48 h and 72 h and then the samples were investigated by GC-FID method and nuclear magnetic resonance (NMR) spectroscopy. According to these results, the degradation products were not o...
متن کاملDispersion of graphene in ethanol using a simple solvent exchange method.
A dispersion of graphene in ethanol was achieved using solvent exchange from N-methyl-2-pyrrolidone (NMP) that enables broader application of dispersed graphene.
متن کاملValidation of an analytical procedure--control of residual solvents in pharmaceutical substance.
In this study elements of validation of headspace GC method of determination of residual methanol, n-pentane, ethanol, tert-butylamine, 2propanol, acetonitrile, dichloromethane and toluene in pharmaceutical substance are presented. Validation of the method included: selectivity, system precision, method precision, accuracy (recovery), limits of detection and quantitation (in substance), robustn...
متن کاملPartial dissolution of ACQ-treated wood in lithium chloride/N-methyl-2-pyrrolidinone: separation of copper from potential lignocellulosic feedstocks.
A cellulose solvent system based on lithium chloride (LiCl) in N-methyl-2-pyrrolidinone (NMP) was used to assess the merits of partial dissolutions of coarsely ground wood samples. Alkaline Copper Quaternary (ACQ)-treated pine wood was of particular interest for treatment given the potential to generate a copper-rich stream apart from solid and/or liquid lignocellulosic feedstocks. Treatment wi...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید
ثبت ناماگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید
ورودعنوان ژورنال:
- Acta poloniae pharmaceutica
دوره 68 2 شماره
صفحات -
تاریخ انتشار 2011