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Related Concept Videos

Clinically Relevant Drug Product Specifications: Methods of Establishment01:29

Clinically Relevant Drug Product Specifications: Methods of Establishment

Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
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Standard solutions refer to solutions with a precisely known concentration or composition. A primary standard is a highly pure, high molar mass, stable substance that is entirely soluble in water, the most commonly used solvent in analytical chemistry. The primary standard solution can be used to standardize secondary standards, which are substances with known concentrations but are less pure and stable. Standard solutions are essential for achieving accurate and reliable results in analytical...
Pharmaceutical Equivalents01:26

Pharmaceutical Equivalents

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.
Chemical Shift: Internal References and Solvent Effects01:17

Chemical Shift: Internal References and Solvent Effects

In an NMR sample, precise measurement of the absolute absorption frequencies of nuclei is difficult. A standard internal reference compound is added, and the frequency difference between the reference signal and sample signals is measured.
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Field Identification of Matricaria chamomilla using a Portable qPCR System
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Published on: October 10, 2020

Herbal reference standards.

Michael Schwarz1, Bernhard Klier, Hartwig Sievers

  • 1PhytoLab GmbH & Co. KG, Vestenbergsgreuth, Germany. michael.schwarz@phytolab.de

Planta Medica
|May 20, 2009
PubMed
Summary
This summary is machine-generated.

This review clarifies definitions and regulations for reference standards in herbal product analysis. It examines the use of reference substances and extracts in major pharmacopoeias.

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Published on: November 4, 2022

Area of Science:

  • Pharmacognosy and Pharmaceutical Analysis
  • Regulatory Science

Background:

  • Accurate analysis of herbal products relies on well-defined reference standards.
  • Regulatory bodies and pharmacopoeias establish requirements for these standards.

Purpose of the Study:

  • To review current definitions and regulatory requirements for reference standards used in herbal product analysis.
  • To discuss the application of reference substances and reference extracts within the European and United States Pharmacopoeias.

Main Methods:

  • Literature review of regulatory documents.
  • Comparative analysis of pharmacopoeial guidelines (European and United States).

Main Results:

  • Current definitions and regulatory frameworks for herbal product reference standards are presented.
  • The utilization of reference substances and extracts in the European Pharmacopoeia and United States Pharmacopeia is detailed.

Conclusions:

  • Harmonization of definitions and regulatory requirements for reference standards is crucial for reliable herbal product analysis.
  • Understanding pharmacopoeial approaches to reference substances and extracts aids in quality control.