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Related Concept Videos

Pharmaceutical Equivalents01:26

Pharmaceutical Equivalents

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As defined by regulatory standards, pharmaceutical equivalents require generic drug products to have identical dosage forms and chemically identical active pharmaceutical ingredients (APIs). They must adhere to compendial or applicable standards for potency, content uniformity, disintegration times, and dissolution rates. In the case of modified-release dosage forms, variations in drug content are permissible as long as the delivered amount remains consistent with the innovator drug product.
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Molecules and Compounds02:38

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All living things are formed mostly of carbon compounds called organic compounds. The category of organic compounds includes both natural and synthetic compounds that contain carbon. Although a single, precise definition has yet to be identified by the chemistry community, most agree that a defining trait of organic molecules is the presence of carbon as the principal element, bonded to hydrogen and other carbon atoms. However, some carbon-containing compounds such as carbonates, cyanides, and...
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Pure substances consist of only one type of matter. A pure substance can be an element or a compound. An element consists of only one type of atom, while a compound consists of two or more types of atoms held together by a chemical bond.
Elements
Elements are classified as atomic or molecular based on the nature of their basic units. They are unique forms of matter with specific chemical and physical properties that cannot break down into smaller substances by ordinary chemical reactions. There...
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Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence01:22

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Generic intravenous (IV) drugs are considered bioequivalent to their branded counterparts due to their 100% bioavailability upon administration. However, variations in stability among different drug products can significantly influence their therapeutic performance, even if they are pharmaceutically equivalent.Cefuroxime, a prophylactic antimicrobial, is often used as a single-dose IV injection for patients undergoing coronary artery bypass grafting surgery. A 3 g dose typically provides...
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Solubility is the measure of the maximum amount of solute that can be dissolved in a given quantity of solvent at a given temperature and pressure. Solubility is usually measured in molarity (M) or moles per liter (mol/L). A compound is termed soluble if it dissolves in water.
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Related Experiment Video

Updated: Feb 10, 2026

Simultaneous Measurement of HDAC1 and HDAC6 Activity in HeLa Cells Using UHPLC-MS
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Automated UHPLC separation of 10 pharmaceutical compounds using software-modeling.

A Zöldhegyi1, H-J Rieger1, I Molnár1

  • 1Molnár-Institute, Schneeglöckchenstrasse 47, 10407 Berlin, Germany.

Journal of Pharmaceutical and Biomedical Analysis
|May 22, 2018
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Summary

Automated analytical method development using software significantly reduces human errors, aligning with FDA

Keywords:
Automated resolution modelingData integrityDryLabIn-silico method developmentReduction of human error in (U)HPLCTime efficiency

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Area of Science:

  • Analytical Chemistry
  • Pharmaceutical Science
  • Regulatory Affairs

Background:

  • Human errors are a significant challenge in regulatory affairs and analytical method development.
  • Compliance with FDA's Data Integrity and Analytical Quality by Design (AQbD) necessitates the elimination of such errors.

Purpose of the Study:

  • To develop smooth, fast, and robust analytical methods free from human failures.
  • To evaluate the effectiveness of state-of-the-art automation in analytical method development.

Main Methods:

  • Utilized commercial software (DryLab) for automated method development.
  • Employed a model mixture of 10 drugs for testing.
  • Applied Analytical Quality by Design (AQbD) principles to select the optimal working point.
  • Performed confirmatory experimental runs based on robustness calculations.

Main Results:

  • Simulated results from the software demonstrated excellent agreement with experimental outcomes.
  • The automated approach proved effective in developing robust analytical methods.
  • Successfully identified and mitigated potential human errors in the method development process.

Conclusions:

  • Software-assisted, automated analytical method development is a viable strategy to enhance data integrity and compliance.
  • This approach effectively minimizes human error, leading to faster and more robust methods.
  • The study validates the use of automation in meeting stringent regulatory requirements like AQbD.