Keywords: ناخالصی های ژنوتوکسیک; In silico methods; QSAR; Expert systems; Genotoxicity; Genotoxic impurities;
مقالات ISI ناخالصی های ژنوتوکسیک (ترجمه نشده)
مقالات زیر هنوز به فارسی ترجمه نشده اند.
در صورتی که به ترجمه آماده هر یک از مقالات زیر نیاز داشته باشید، می توانید سفارش دهید تا مترجمان با تجربه این مجموعه در اسرع وقت آن را برای شما ترجمه نمایند.
در صورتی که به ترجمه آماده هر یک از مقالات زیر نیاز داشته باشید، می توانید سفارش دهید تا مترجمان با تجربه این مجموعه در اسرع وقت آن را برای شما ترجمه نمایند.
Keywords: ناخالصی های ژنوتوکسیک; Genotoxic impurities; (Q)SAR analysis; Ames test; Chromosomal aberration test; Hplc; Regulations;
Keywords: ناخالصی های ژنوتوکسیک; ICH M7; Computational toxicology; Genotoxic impurities; Structure-activity relationships;
Keywords: ناخالصی های ژنوتوکسیک; Active pharmaceutical ingredients; Aminopyridines; Genotoxic impurities; Molecularly imprinted polymers;
Keywords: ناخالصی های ژنوتوکسیک; Genotoxic impurities; In silico; (Q)SAR; Mutagenicity; ICH M7;
Chemometrically assisted development and validation of LC-MS/MS method for the analysis of potential genotoxic impurities in meropenem active pharmaceutical ingredient
Keywords: ناخالصی های ژنوتوکسیک; Meropenem; LC-MS/MS; Genotoxic impurities; Box-Behnken; Grid point search methodology;
Selective scavenging of the genotoxic impurity methyl p-toluenesulfonate from pharmaceutical formulations
Keywords: ناخالصی های ژنوتوکسیک; Methyl p-toluenesulfonate; Genotoxic impurities; Pharmaceutical formulations
The Assessment of Impurities for Genotoxic Potential and Subsequent Control in Drug Substance and Drug Product
Keywords: ناخالصی های ژنوتوکسیک; genotoxic impurities; analytical chemistry; toxicology; regulatory science; in silico modeling; stability; degradation; control strategy; risk assessment; threshold of toxicological concern;
Simultaneous determination of alkyl mesilates and alkyl besilates in finished drug products by direct injection GC/MS
Keywords: ناخالصی های ژنوتوکسیک; Alkyl mesilates; Alkyl besilates; GC/MS; Genotoxic Impurities; Liquid–liquid extraction
A new liquid chromatography–mass spectrometry approach for generic screening and quantitation of potential genotoxic alkylation compounds without derivatization
Keywords: ناخالصی های ژنوتوکسیک; Genotoxic impurities; Pharmaceutical formulation; Underivatized alkylating agents; LC–MS; Direct-EI interface
Development of chromatographic methods for the determination of genotoxic impurities in cloperastine fendizoate
Keywords: ناخالصی های ژنوتوکسیک; 2-CE, 2-chloroethanol; MPTS, methyl p-toluenesulfonate; CEPTS, 2-chloroethyl p-toluenesulfonate; API, active pharmaceutical ingredient; GTI, genotoxic impurity; SS, solvent solutionCloperastine fendizoate; Genotoxic impurities; Sulfonate esters; Alkyl hal
In silico methods combined with expert knowledge rule out mutagenic potential of pharmaceutical impurities: An industry survey
Keywords: ناخالصی های ژنوتوکسیک; Genotoxic impurities; In silico; (Q)SAR; Mutagenicity
Removal of potentially genotoxic acetamide and arylsulfonate impurities from crude drugs by molecular imprinting
Keywords: ناخالصی های ژنوتوکسیک; Molecular imprinting; Genotoxic impurities; API purification; Solid-phase extraction
Design, preparation and characterization of novel molecularly imprinted polymers for removal of potentially genotoxic 1,3-diisopropylurea from API solutions
Keywords: ناخالصی های ژنوتوکسیک; Molecular imprinting; API purification; Genotoxic impurities; Pharmaceuticals; Host-guest system; 1,3-Diisopropylurea
A hybrid approach to reach stringent low genotoxic impurity contents in active pharmaceutical ingredients: Combining molecularly imprinted polymers and organic solvent nanofiltration for removal of 1,3-diisopropylurea
Keywords: ناخالصی های ژنوتوکسیک; Molecularly imprinted polymers; Organic solvent nanofiltration; API purification; Genotoxic impurities
Selective extraction of genotoxic impurities and structurally alerting compounds using polymeric ionic liquid sorbent coatings in solid-phase microextraction: Alkyl halides and aromatics
Keywords: ناخالصی های ژنوتوکسیک; Ionic liquids; Polymeric ionic liquids; Solid-phase microextraction; Genotoxic impurities; DNA intercalators; DNA alkylators
Strategies for the identification, control and determination of genotoxic impurities in drug substances: A pharmaceutical industry perspective
Keywords: ناخالصی های ژنوتوکسیک; Identification; Control; Genotoxic impurities; Drug substances; Pharmaceutical industry
Organic solvent nanofiltration: A platform for removal of genotoxins from active pharmaceutical ingredients
Keywords: ناخالصی های ژنوتوکسیک; Organic solvent nanofiltration; Genotoxic impurities; Active pharmaceutical ingredient; Purification;
Overall impact of the regulatory requirements for genotoxic impurities on the drug development process
Keywords: ناخالصی های ژنوتوکسیک; Genotoxic impurities; ICH guidelines; GTI toxicological assessment; GTI analysis; Analytical control strategy; Quality by design
Recent advances in trace analysis of pharmaceutical genotoxic impurities
Keywords: ناخالصی های ژنوتوکسیک; Genotoxic impurities; Trace analysis; Method development; Chemical derivatization; Matrix deactivation; Unstable/reactive analytes; Coordination ion spray-mass spectrometry
The Threshold of Toxicological Concern (TTC) in risk assessment
Keywords: ناخالصی های ژنوتوکسیک; Risk assessment; Threshold of Toxicological Concern (TTC); Flavouring substances; Cosmetics; Household products; Genotoxic impurities
Toxicological overview of impurities in pharmaceutical products
Keywords: ناخالصی های ژنوتوکسیک; Toxicology; Pharmaceutical impurities; European Medicines Agency (EMEA); Genotoxic impurities
The application of structure-based assessment to support safety and chemistry diligence to manage genotoxic impurities in active pharmaceutical ingredients during drug development
Keywords: ناخالصی های ژنوتوکسیک; Genotoxic impurities; Structure–activity relationship; Synthetic intermediates; Structural alerts; Genetic safety; Mutagens; Carcinogens; Analytical measurement; Process control