相关参考文献
注意：仅列出部分参考文献，下载原文获取全部文献信息。Simultaneous and trace level quantification of two potential genotoxic impurities in valsartan drug substance using UPLC-MS/MS
Shuhong Li et al.
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS (2022)
Determination of Methyl Methanesulfonate and Ethyl Methylsulfonate in New Drug for the Treatment of Fatty Liver Using Derivatization Followed by High-Performance Liquid Chromatography with Ultraviolet Detection
Yue Wang et al.
MOLECULES (2022)
Ultra high-performance liquid chromatography method development for separation of formoterol, budesonide, and related substances using an analytical quality by design approach
Fadi L. Alkhateeb et al.
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS (2021)
Validated Modernized Assay for Foscarnet in Pharmaceutical Formulations Using Suppressed Ion Chromatography Developed through a Quality by Design Approach
Ngoc Phuoc Dinh et al.
SEPARATIONS (2021)
Development of a Fast and Robust UHPLC Method for Apixaban In-Process Control Analysis
Robert Kormany et al.
MOLECULES (2021)
Development of a Unified Reversed-Phase HPLC Method for Efficient Determination of EP and USP Process-Related Impurities in Celecoxib Using Analytical Quality by Design Principles
Tim Tome et al.
MOLECULES (2020)
Development of a Stability-Indicating Analytical Method for Determination of Venetoclax Using AQbD Principles
Nina Zigart et al.
ACS OMEGA (2020)
Developing an Improved UHPLC Method for Efficient Determination of European Pharmacopeia Process-Related Impurities in Ropinirole Hydrochloride Using Analytical Quality by Design Principles
Tim Tome et al.
MOLECULES (2020)
Systematic development of a bioanalytical UPLC-MS/MS method for estimation of risperidone and its active metabolite in long-acting microsphere formulation in rat plasma
Rehan Abdur Rub et al.
JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES (2020)
A simple, sensitive, high-resolution, customized, reverse phase ultra-high performance liquid chromatographic method for related substances of a therapeutic peptide (bivalirudin trifluoroacetate) using the quality by design approach
K. Y. Kiran Kumar et al.
ANALYTICAL METHODS (2020)
Trace level quantification of 1-(3-chloropropyl)-4-(3-chlorophenyl)piperazine HCl genotoxic impurity in trazodone using LC-MS/MS
Nandigam Venugopal et al.
ARABIAN JOURNAL OF CHEMISTRY (2019)
Quality by Design oriented development of hydrophilic interaction liquid chromatography method for the analysis of amitriptyline and its impurities
Irena Kasagic-Vujanovic et al.
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS (2019)
Development and Optimization of Liquid Chromatography Analytical Methods by Using AQbD Principles: Overview and Recent Advances
Tim Tome et al.
ORGANIC PROCESS RESEARCH & DEVELOPMENT (2019)
Development and validation of a sensitive method for alkyl sulfonate genotoxic impurities determination in drug substances using gas chromatography coupled to triple quadrupole mass spectrometry
Zhen Liu et al.
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS (2019)
A new HPLC-UV derivatization approach for the determination of potential genotoxic benzyl halides in drug substances
Shunli Ji et al.
RSC ADVANCES (2019)
Potential impurities in drug substances: Compound-specific toxicology limits for 20 synthetic reagents and by-products, and a class-specific toxicology limit for alkyl bromides
J. P. Bercu et al.
REGULATORY TOXICOLOGY AND PHARMACOLOGY (2018)
'Quality by Design' approach for the analysis of impurities in pharmaceutical drug products and drug substances
Amandine Dispas et al.
TRAC-TRENDS IN ANALYTICAL CHEMISTRY (2018)
Application of quality by design concept to develop a dual gradient elution stability-indicating method for cloxacillin forced degradation studies using combined mixture-process variable models
Xia Zhang et al.
JOURNAL OF CHROMATOGRAPHY A (2017)
Recent advances in analysis of hazardous genotoxic impurities in pharmaceuticals by HPLC, GC, and CE
Khaldun M. Al Azzam et al.
JOURNAL OF LIQUID CHROMATOGRAPHY & RELATED TECHNOLOGIES (2016)
Principles and procedures for implementation of ICH M7 recommended (Q)SAR analyses
Alexander Amberg et al.
REGULATORY TOXICOLOGY AND PHARMACOLOGY (2016)
Genotoxic Impurities in Pharmaceutical Manufacturing: Sources, Regulations, and Mitigation
Gyorgy Szekely et al.
CHEMICAL REVIEWS (2015)
Derivatization of genotoxic nitroaromatic impurities for trace analysis by LC-MS
Xinghua Wu et al.
ANALYTICAL METHODS (2014)
Determination of trace level genotoxic impurities in small molecule drug substances using conventional headspace gas chromatography with contemporary ionic liquid diluents and electron capture detection
Tien D. Ho et al.
JOURNAL OF CHROMATOGRAPHY A (2014)
A validated CE method for determining dimethylsulfate a carcinogen and chloroacetyl chloride a potential genotoxin at trace levels in drug substances
Muzaffar Khan et al.
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS (2012)
Strategies for the identification, control and determination of genotoxic impurities in drug substances: A pharmaceutical industry perspective
N. V. V. S. S. Raman et al.
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS (2011)
Recent advances in trace analysis of pharmaceutical genotoxic impurities
David Q. Liu et al.
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS (2010)
Risk Assessment of Potentially Genotoxic Impurities within the Framework of Quality by Design
Adam R. Looker et al.
ORGANIC PROCESS RESEARCH & DEVELOPMENT (2010)
Overview of Genotoxic Impurities in Pharmaceutical Development
Joel P. Bercu et al.
INTERNATIONAL JOURNAL OF TOXICOLOGY (2009)
Development, validation and transfer into a factory environment of a liquid chromatography tandem mass spectrometry assay for the highly neurotoxic impurity FMTP (4-(4-fluorophenyl)-1-methyl-1,2,3,6-tetrahydropyridine) in paroxetine active pharmaceutical ingredient (API)
Phil J. Borman et al.
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS (2008)
Control and analysis of alkyl and benzyl halides and other related reactive organohalides as potential genotoxic impurities in active pharmaceutical ingredients (APIs)
D. P. Elder et al.
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS (2008)
Genotoxicity profiles of common alkyl halides and esters with alkylating activity
Z. Sobol et al.
MUTATION RESEARCH-GENETIC TOXICOLOGY AND ENVIRONMENTAL MUTAGENESIS (2007)
A compilation of two decades of mutagenicity test results with the ames Salmonella typhimurium and L5178Y mouse lymphoma cell mutation assays
H. E. Seifried et al.
CHEMICAL RESEARCH IN TOXICOLOGY (2006)
A rationale for determining, testing, and controlling specific impurities in pharmaceuticals that possess potential for genotoxicity
L Müller et al.
REGULATORY TOXICOLOGY AND PHARMACOLOGY (2006)
分享论文
