87 results match your criteria: "Jiangsu Institute for Food and Drug Control[Affiliation]"
Magn Reson Chem
September 2025
Jiangsu Institute for Food and Drug Control (JSIFDC), Nanjing, Jiangsu, China.
The research team established a quantitative H NMR method to determine the relative ethoxy content (EO%) in ethylcellulose using a CDCl/TFA-d solvent mixture. High-field NMR spectroscopy enabled direct measurement without the use of internal or external calibrants by integrating the methyl proton signals (δ 1.15 ppm) and the methylene/methine proton signals (δ 2.
View Article and Find Full Text PDFJ Pharm Biomed Anal
November 2025
Jiangsu Institute for Food and Drug Control, Nanjing 210019, China; National Medical Products Administration Key Laboratory for Impurity Profile of Chemical Drugs, Nanjing 210019, China. Electronic address:
Fatty oils are essential in the pharmaceutical field for enhancing the solubility and oral bioavailability of drugs, as well as reducing the risk of cardiovascular diseases. Consequently, detecting adulteration in specific fatty oils is critical to ensuring pharmaceutical quality and safety. In this study, we present a rapid method for classifying and detecting adulteration that combines supervised machine learning (ML) with supercritical fluid chromatography-mass spectrometry (SFC-MS).
View Article and Find Full Text PDFJ Chromatogr A
April 2025
NMPA Key Laboratory for Impurity Profile of Chemical Drugs, Jiangsu Institute for Food and Drug Control, Nanjing 210019, PR China. Electronic address:
Rifampicin (RIF) is a kind of semi-synthetic antibiotic with broad-spectrum antibacterial action, which has remarkable antibacterial activity against many pathogenic microorganisms. The World Health Organization classifies RIF as critically important for human medicine, especially for tuberculosis treatment. The polymorphic nature of RIF contributes to the complexity of the impurities of the drug.
View Article and Find Full Text PDFJ Pharm Anal
February 2025
School of Chemistry and Chemical Engineering, Nanjing University, Nanjing, 210046, China.
In-depth study of the components of polymyxins is the key to controlling the quality of this class of antibiotics. Similarities and variations of components present significant analytical challenges. A two-dimensional (2D) liquid chromatography-mass spectrometr (LC-MS) method was established for screening and comprehensive profiling of compositions of the antibiotic colistimethate sodium (CMS).
View Article and Find Full Text PDFJ Hazard Mater
April 2025
Jiangsu Institute for Food and Drug Control, 6 Beijing West Road, Nanjing 210008, China. Electronic address:
Chlorpromazine (CPZ) is an abused sedative that is extensively metabolized in organisms. However, the metabolic pathway of CPZ in aquatic organisms is still unclear. In this study, CPZ metabolites was analyzed in grass carp exposed to CPZ in the raising water using ultrahigh-performance liquid chromatography coupled with quadrupole Orbitrap mass spectrometry (UHPLC-Q-Orbitrap MS).
View Article and Find Full Text PDFInt J Nanomedicine
November 2024
College of Animal Medicine, Jiangsu Agri-Animal Husbandry Vocational College, Taizhou, People's Republic of China.
Introduction: Eprinomectin offers promise against parasitic infections. This study develops Eprinomectin (EPR) mixed micelles for transdermal delivery, aiming to enhance efficacy and convenience against endoparasites and ectoparasites. Physicochemical characterization and pharmacokinetic studies were conducted to assess its potential as an effective treatment for parasitic infections.
View Article and Find Full Text PDFPharmaceutics
September 2024
Department of Pharmacy, Nanjing Drum Tower Hospital Clinical College of Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine, Nanjing 210008, China.
J Chromatogr A
November 2024
Jiangsu Institute for Food and Drug Control, Nanjing 210019, China; NMPA Key Laboratory for Impurity Profile of Chemical Drugs, Nanjing 210019, China. Electronic address:
Ethylene glycol (EG) and diethylene glycol (DEG) are two contaminants known to cause a variety of human health problems, when ingested in certain amounts, they can cause adverse effects such as nephrotoxicity, neurotoxicity and even death. They are widely found in propylene glycol, which is commonly used as a base for pharmaceutical syrups. The aim of this study was to develop an analytical method for the evaluation of EG and DEG in commercially available pediatric syrups.
View Article and Find Full Text PDFACS Sens
October 2024
School of Environmental and Chemical Engineering, Jiangsu University of Science and Technology, Zhenjiang, Jiangsu 212003, PR China.
Talanta
January 2025
Department of Pharmaceutics, School of Pharmacy, China Pharmaceutical University, Nanjing, 210019, Jiangsu Province, People's Republic of China. Electronic address:
Anal Methods
November 2024
School of Pharmacy, Anhui University of Chinese Medicine, Hefei 230012, China.
Chemical hair dye components can have allergenic, reproductive, and carcinogenic risks. Detecting restricted and prohibited ingredients in these products is challenging due to product diversity, isomer separation, instability, and wide polarity range. A method was developed using HPLC-high-resolution mass spectrometry for the qualitative and quantitative analysis of 54 hair dye components in various products.
View Article and Find Full Text PDFJ Pharm Biomed Anal
January 2025
Jiangsu Institute for Food and Drug Control, Nanjing 210019, China; NMPA Key Laboratory for Impurity Profile of Chemical Drugs, Nanjing 210019, China. Electronic address:
J Pharm Biomed Anal
October 2024
State Key Laboratory of Analytical Chemistry for Life Science, School of Chemistry and Chemical Engineering, Nanjing University, Nanjing 210023, China. Electronic address:
The pollution of mycotoxins to crops such as traditional Chinese medicines (TCMs) is an established problem throughout the world. Thus, mycotoxin determination in TCMs during production and processing is significantly necessary, which means rapid, sensitive and accurate analytical methods are needed. In this work, a new method of visual protein microarray based on a 96-well microtiter plate was proposed.
View Article and Find Full Text PDFAdv Sci (Weinh)
August 2024
School of Chemical Engineering and Technology, Xi'an Jiaotong University, Xi'an, 710049, P. R. China.
The transition metal-catalyzed multi-component cross-electrophile sulfonylation, which incorporates SO as a linker within organic frameworks, has proven to be a powerful, efficient, and cost-effective means of synthesizing challenging alkyl-alkyl sulfones. Transition metal catalysts play a crucial role in this method by transferring electrons from reductants to electrophilic organohalides, thereby causing undesirable side reactions such as homocoupling, protodehalogenation, β-hydride elimination, etc. It is worth noting that tertiary alkyl halides have rarely been demonstrated to be compatible with current methods owing to various undesired side reactions.
View Article and Find Full Text PDFTalanta
September 2024
Jiangsu Institute for Food and Drug Control, Nanjing, 210019, China; NMPA Key Laboratory for Impurity Profile of Chemical Drugs, Nanjing, 210019, China. Electronic address:
Se Pu
June 2024
College of Environmental and Chemical Engineering, Jiangsu University of Science and Technology, Zhenjiang 212003, China.
Talanta
September 2024
School of Chemistry and Chemical Engineering, State Key Laboratory of Analytical Chemistry for Life Science, Nanjing University, Nanjing, China. Electronic address:
Combination drug therapy represents an effective strategy for treating certain drug-resistant and intractable cancer cases. However, determining the optimal combination of drugs and dosages is challenging due to clonal diversity in patients' tumors and the lack of rapid drug sensitivity evaluation methods. Microfluidic technology offers promising solutions to this issue.
View Article and Find Full Text PDFAnalyzing polysorbate 20 (PS20) composition and the impact of each component on stability and safety is crucial due to formulation variations and individual tolerance. The similar structures and polarities of PS20 components make accurate separation, identification, and quantification challenging. In this work, a high-resolution quantitative method was developed using single-dimensional high-performance liquid chromatography (HPLC) with charged aerosol detection (CAD) to separate 18 key components with multiple esters.
View Article and Find Full Text PDFLiver Int
August 2024
Jiangsu Key Laboratory of Druggability of Biopharmaceuticals and State Key Laboratory of Natural Medicines, School of Life Science and Technology, China Pharmaceutical University, Nanjing, China.
Non-alcoholic fatty liver disease (NAFLD) has emerged as the most prevalent chronic liver disease globally. Non-alcoholic steatohepatitis (NASH) represents an extremely progressive form of NAFLD, which, without timely intervention, may progress to cirrhosis or hepatocellular carcinoma. Presently, a definitive comprehension of the pathogenesis of NAFLD/NASH eludes us, and pharmacological interventions targeting NASH specifically remain constrained.
View Article and Find Full Text PDFAAPS PharmSciTech
April 2024
Jiangsu Institute for Food and Drug Control, Jiangsu Province, Nanjing, China.
Purpose: Dry eye syndrome (DES), arising from various etiologic factors, leads to tear film instability and ocular surface damage. Given its anti-inflammatory effects, cyclosporine A (CsA) has been widely used as a short-term treatment option for DES. However, poor bioavailability and solubility of CsA in aqueous phase make the development of a cyclosporine A-based eye drop for ocular topical application a huge challenge.
View Article and Find Full Text PDFViruses
April 2024
Institute of Biological Products, National Institutes for Food and Drug Control, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, State Key Laboratory of Drug Regulatory Science, Beijing 102629, China.
Neutralizing antibodies (NtAbs) against severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) are indicators of vaccine efficacy that enable immunity surveillance. However, the rapid mutation of SARS-CoV-2 variants prevents the timely establishment of standards required for effective XBB vaccine evaluation. Therefore, we prepared four candidate standards (No.
View Article and Find Full Text PDFSe Pu
April 2024
1. Nanjing Medical University, Nanjing 211166, China.
Open experiments are an effective means of cultivating top-notch innovative talents. Based on student interests, research hotspots and our laboratory conditions, an experimental scheme was designed. In this experiment, polyethyleneimine modified carbon dots (PEI-CDs) were prepared via a one-step hydrothermal method using citric acid (CA) as the carbon source and PEI as the surface passivator.
View Article and Find Full Text PDFTalanta
June 2024
Department of TCMs Pharmaceuticals, China Pharmaceutical University, Nanjing, 211198, China. Electronic address:
Current genotoxicity assessment methods are mainly employed to verify the genotoxic safety of drugs, but do not allow for rapid screening of specific genotoxic impurities (GTIs). In this study, a new approach for the recognition of GTIs has been proposed. It is to expose the complex samples to an in vitro nucleoside incubation model, and then draw complete DNA adduct profiles to infer the structures of potential genotoxic impurities (PGIs).
View Article and Find Full Text PDFTalanta
May 2024
School of Environmental and Chemical Engineering, Jiangsu University of Science and Technology, Zhenjiang, 212003, Jiangsu Province, PR China; College of Chemistry, Chemical Engineering and Materials Science, Soochow University, Suzhou, 215123, PR China. Electronic address:
In this study, a novel integrated liposome-based microfluidic platform combined with a smartphone was designed for the rapid colorimetric detection of microRNA-21 (miRNA-21) in real samples. The flowing surface-functionalized liposomes were first captured by nucleic acid-functionalized Au nanoparticles in the microfluidic chip. In the presence of miRNA-21, the DNA strand modified on the surface of Au nanoparticles hybridized with the target to form double-stranded products and was cleaved by duplex-specific nuclease (DSN) enzyme, causing the liposomes to be re-released.
View Article and Find Full Text PDFEnviron Sci Pollut Res Int
March 2024
Jiangsu Institute for Food and Drug Control, Nanjing, 210019, People's Republic of China.
Minimal research exists on polychlorinated biphenyl (PCB) exposure from traditional Chinese medicines (TCMs), despite their significant contributions to domestic and international health protection. This study is the first to investigate the levels, profiles, and health risks of PCB residue in Pheretima, a typical TCM produced from earthworm. Seventy-seven Pheretima samples from different regions of China were analyzed for 45 PCB congeners.
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