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Control of Genotoxic Impurities in Active Pharmaceutical Ingredients: A Review and Perspective
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What this work says
Outgoing claims: the papers this work cites, builds on, or argues with.
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Incoming claims: where this work appears in other papers’ reference lists and arguments.
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inferred← citeshttps://doi.org/10.1088/2053-1591/3/10/106203openalex-snapshot
Crystal growth, perfection, linear and nonlinear optical, photoconductivity, dielectric, thermal and laser damage threshold properties of 4-methylimidazolium picrate: an interesting organic crystal for photonic and optoelectronic devices
inferred← citeshttps://doi.org/10.1093/chromsci/bmaa100openalex-snapshot
Determination of Potential Genotoxic Impurity, 5-Amino-2-Chloropyridine, in Active Pharmaceutical Ingredient Using the HPLC-UV System
inferred← citeshttps://doi.org/10.1093/chromsci/bmab139openalex-snapshot
Determination of Potential Genotoxic Impurities (Orthophenylene Diamine Dihydrochloride), 4’-Bromomethyl-2-Cyanobiphenyl, 4’(Dibromomethyl)[1,1’-Biphenyl]-2-Carbonitrile in Telmisartan by ESI-MS/MS
inferred← citeshttps://doi.org/10.1107/s0108270110034657openalex-snapshot
Two three-dimensional networks in two polymorphs of biphenyl-4,4′-diaminium bis(3-carboxy-4-hydroxybenzenesulfonate) dihydrate
inferred← citeshttps://doi.org/10.1107/s205698901600712xopenalex-snapshot
Hydrogen-bonded network in the salt 4-methyl-1H-imidazol-3-ium picrate
inferred← citeshttps://doi.org/10.1107/s2056989017016401openalex-snapshot
Stoichiometric and polymorphic salt of imidazolium picrate monohydrate
inferred← citeshttps://doi.org/10.1186/s40360-019-0354-2openalex-snapshot
In vitro toxic evaluation of two gliptins and their main impurities of synthesis
inferred← citeshttps://doi.org/10.1186/s40543-021-00273-7openalex-snapshot
An efficient HILIC-MS/MS method for the trace level determination of three potential genotoxic impurities in aripiprazole active drug substance
inferred← citeshttps://doi.org/10.1186/s43094-021-00338-9openalex-snapshot
Liquid chromatography-tandem mass spectrometric method for trace quantification of ethyl methanesulfonate: a genotoxic impurity in dapoxetine hydrochloride
inferred← citeshttps://doi.org/10.1201/9781315367316-11openalex-snapshot
Reagents for Amide Formation
inferred← citeshttps://doi.org/10.1201/b17350-18openalex-snapshot
Salt Formation of Pharmaceutical Compounds and Associated Genotoxic Risks
inferred← citeshttps://doi.org/10.13005/ojc/420424openalex-snapshot
Navigating Advances and Challenges in Pharmaceutical Impurity Characterization and Quantification
inferred← citeshttps://doi.org/10.14233/ajchem.2022.26905openalex-snapshot
Detection and Quantification of Two Potential Genotoxic Impurities in Telbivudine Active Pharmaceutical Ingredient by Targeted Ultra Performance LC-MS/MS Analysis
inferred← citeshttps://doi.org/10.14233/ajchem.2024.30736openalex-snapshot
In silico Toxicity Assessment and Quantification of Potential Genotoxic Impurity in Olmesartan Medoxomil Drug Substance using GC-MS/MS
inferred← citeshttps://doi.org/10.15272/ajbps.v6i53.770openalex-snapshot
Optimization and validation of RP-HPLC method for the estimation of meloxicam andparacetamol with its genotoxic impurity (p-amino phenol) in bulk and pharmaceutical drugproduct using PDA detector
inferred← citeshttps://doi.org/10.19080/omcij.2019.08.555739openalex-snapshot
NNRTI (Non-Nucleoside Reverse Transcriptase Inhibitor) Drug AZT and Their Preparation & Determination A Patent Evaluation of Efavirenz
inferred← citeshttps://doi.org/10.2116/analsci.30.377openalex-snapshot
Novel Sensitive Determination Method for a Genotoxic Alkylating Agent, 4-Chloro-1-butanol, in Active Pharmaceutical Ingredients by LC-ICP-MS Employing Iodo Derivatization
inferred← citeshttps://doi.org/10.2116/analsci.30.845openalex-snapshot
Sensitive Quantitation of Residual Phenylhydrazine in Antipyrine by LC-ICP-MS with Iodo Derivatization
inferred← citeshttps://doi.org/10.2139/ssrn.6899834openalex-snapshot
Development and Validation of a GC–MS Method for Trace-Level Determination of Dimethyl Sulfate, Diethyl sulfate and Diisopropyl Sulfate Genotoxic Impurities in Hydroxychloroquine Sulfate
inferred← citeshttps://doi.org/10.2174/1389201024666230726152629openalex-snapshot
Genotoxic Impurities in Critical Analysis of Product Development: Recent Advancements, Patents, and Current Challenges
inferred← citeshttps://doi.org/10.2174/1573412918666220426111507openalex-snapshot
GC-FID Quantification of N, N-Dimethyl Aminopropyl Chloride, a Genotoxic Impurity, in Imipramine Hydrochloride and Clomipramine Hydrochloride
inferred← citeshttps://doi.org/10.22159/ajpcr.2020.v13i6.37370openalex-snapshot
GENOTOXIC IMPURITIES: AN IMPORTANT REGULATORY ASPECT
inferred← citeshttps://doi.org/10.22159/ijap.2021v13i3.40911openalex-snapshot
A SELECTIVE AND SENSITIVE LC-MS/MS METHOD FOR QUANTIFICATION OF FOUR POTENTIAL GENOTOXIC IMPURITIES IN ATAZANAVIR SULFATE DRUG SUBSTANCE IN TRACE LEVEL
inferred← citeshttps://doi.org/10.31788/rjc.2022.1536954openalex-snapshot
ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF GENOTOXIC IMPURITY p-ANISALDEHYDE IN TENELIGLIPTIN USING GC-MS
inferred← citeshttps://doi.org/10.31788/rjc.2022.1536966openalex-snapshot
CHARACTERISATION AND EVALUATION OF THE TRACE LEVEL OF GENOTOXIC IMPURITIES IN BICTEGRAVIR SODIUM DRUG SUBSTANCE BY USING LIQUID CHROMATOGRAPHY-MASS SPECTROSCOPY
inferred← citeshttps://doi.org/10.32474/ddipij.2018.02.000143openalex-snapshot
Genotoxic Impurities and Its Risk Assessment in Drug Compounds
inferred← citeshttps://doi.org/10.3390/jox14020042openalex-snapshot
A Review on Fluoroquinolones’ Toxicity to Freshwater Organisms and a Risk Assessment
inferred← citeshttps://doi.org/10.3390/scipharm84030456openalex-snapshot
Trace Level Quantification of the (−)2-(2-amino-5-chlorophenyl)-4-cyclopropyl-1,1,1-trifluoro-3-butyn-2-ol Genotoxic Impurity in Efavirenz Drug Substance and Drug Product Using LC–MS/MS
inferred← citeshttps://doi.org/10.3797/scipharm.1502-05openalex-snapshot
A Validated HPLC/MS Limit Test Method for a Potential Genotoxic Impurity in Cilostazol and its Quantification in the API and in the Commercially Available Drug Product
inferred← citeshttps://doi.org/10.4103/ajprhc.ajprhc_107_24openalex-snapshot
Regulatory Submission Templates for Elemental Impurities, Genotoxic Impurities, and Nitrosamine Impurities of Pharmaceutical Drug Substances
inferred← citeshttps://doi.org/10.53730/ijhs.v6ns7.12710openalex-snapshot
Review on identification and quantification of genotoxic impurities
inferred← citeshttps://doi.org/10.5731/pdajpst.2014.00974openalex-snapshot
Advice on Degradation Products in Pharmaceuticals: A Toxicological Evaluation
inferred← citeshttps://doi.org/10.5772/24030openalex-snapshot
Genotoxic Impurities in Pharmaceuticals
inferred← citeshttps://doi.org/10.5897/jtehs2014.0313openalex-snapshot
Determination of the effects of some artificial sweeteners on human peripheral lymphocytes using the comet assay
inferred← citeshttps://doi.org/10.7324/japs.2024.182017openalex-snapshot
The development of a GC-FID method for indirect quantification of chloroacetyl chloride, a potential genotoxic impurity,in chlordiazepoxide hydrochloride drug substance
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