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Related Concept Videos

Drug Dissolution: Requirements and Profile Comparison01:14

Drug Dissolution: Requirements and Profile Comparison

The acceptance criteria for dissolution profile data are anchored in Q values, representing the percentage of drug dissolved within a specified period. This assessment unfolds in three stages:First Stage: The test passes if all six drug dosage units are equal to or greater than Q plus 5%; otherwise, the sample proceeds to the second stage.Second Stage: The average of twelve units must be equal to or greater than Q, with no unit falling below Q - 15% to pass; if not, it progresses to the final...
Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence01:19

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Pharmaceutical products contain more than just the active drug; they also contain various excipients such as binders, solubilizers, stabilizers, preservatives, and other elements. In some cases, impurities or contaminants might be present. Traditionally, quality control in pharmaceuticals has primarily focused on the analysis of the active drug, often overlooking the impact of these additional components. The recent issue with heparin contamination by over-sulfated chondroitin sulfate, a...

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Related Experiment Video

Updated: Jun 28, 2026

High-throughput and Comprehensive Drug Surveillance Using Multisegment Injection-Capillary Electrophoresis-Mass Spectrometry
10:17

High-throughput and Comprehensive Drug Surveillance Using Multisegment Injection-Capillary Electrophoresis-Mass Spectrometry

Published on: April 23, 2019

Drug impurity profiling strategies.

S Görög1, M Babják, G Balogh

  • 1Chemical Works of Gedeon Richter Ltd., P.O.B. 27, H-1475 Budapest, Hungary.

Talanta
|October 31, 2008
PubMed
Summary
This summary is machine-generated.

This study presents a comprehensive scheme for estimating drug substance impurity profiles using chromatography and spectroscopy. The methods, including GC/MS and HPLC/MS, identify and quantify impurities in pharmaceutical compounds.

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Area of Science:

  • Analytical Chemistry
  • Pharmaceutical Analysis
  • Chromatography and Spectroscopy

Background:

  • Accurate impurity profiling is crucial for drug substance quality and safety.
  • A systematic approach is needed to integrate various analytical techniques for comprehensive impurity analysis.

Purpose of the Study:

  • To establish a general scheme for estimating the impurity profile of bulk drug substances.
  • To illustrate the application of chromatographic, spectroscopic, and hyphenated techniques in impurity identification and quantification.

Main Methods:

  • Utilized thin-layer chromatography (TLC), gas chromatography (GC), and high-performance liquid chromatography (HPLC).
  • Employed mass spectrometry (MS) and NMR spectroscopy for structural elucidation.
  • Applied hyphenated techniques such as HPLC with diode-array UV detection, GC/MS, and HPLC/MS.

Main Results:

  • Successfully identified a specific impurity (propyl 4-[diethylcarbamoyl(methoxy)]-3-methoxy phenylglyoxylate) in propanidid.
  • Detected two unsaturated impurities in allylstrenol.
  • Estimated the impurity profile of mazipredone using advanced hyphenated techniques.

Conclusions:

  • The proposed scheme effectively integrates diverse analytical methods for robust impurity profiling.
  • Demonstrated the utility of GC/MS, HPLC/diode-array UV, and HPLC/MS in characterizing complex impurity profiles of drug substances.