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Related Concept Videos

Instrument Calibration01:12

Instrument Calibration

Instrument calibration is essential for ensuring that instruments produce accurate and consistent results. It is vital in manufacturing, healthcare, testing laboratories, and scientific research. Calibration processes are specific to each instrument and help enhance data accuracy. Each instrument has a unique calibration process tailored to its design and function to improve data accuracy.
Analytical Balance Calibration
An analytical balance measures mass and requires regular calibration to...
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.
The internal reference compound generally used in NMR spectroscopy is tetramethylsilane (TMS). TMS is preferred because it is chemically inert, soluble in NMR solvents, and easily removable. Also, the highly shielded methyl protons in TMS yield an intense...
Calibration Curves: Linear Least Squares01:20

Calibration Curves: Linear Least Squares

A calibration curve is a plot of the instrument's response against a series of known concentrations of a substance. This curve is used to set the instrument response levels, using the substance and its concentrations as standards. Alternatively, or additionally, an equation is fitted to the calibration curve plot and subsequently used to calculate the unknown concentrations of other samples reliably.
For data that follow a straight line, the standard method for fitting is the linear...
NMR Spectrometers: Overview01:20

NMR Spectrometers: Overview

NMR spectrometers consist of a strong magnet, a radiofrequency transmitter, and a detector attached to a computer console for recording spectra of samples containing NMR-active nuclei. In first-generation NMR instruments called continuous-wave spectrometers, the resonance frequencies of the nuclei are determined by frequency-sweep or field-sweep methods. The magnetic field strength is fixed and the rf signal is swept in the former, while the radiofrequency signal is fixed and the magnetic field...
Atomic Absorption Spectroscopy: Lab01:21

Atomic Absorption Spectroscopy: Lab

For AAS measurements, samples must be introduced as clear solutions, often requiring extensive preliminary treatment to dissolve materials like soils, animal tissues, and minerals. Common methods for sample preparation include treatment with hot mineral acids, wet ashing, combustion in closed containers, high-temperature ashing, or fusion with reagents.
 Solutions containing organic solvents, such as low-molecular-mass alcohols, esters, or ketones, enhance absorbances by increasing nebulizer...

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Related Experiment Video

Updated: Jul 13, 2026

Application and Methodology of the Non-destructive 19F Time-domain NMR Technique to Measure the Content in Fluorine-containing Drug Products
09:24

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Preparing calibration sets for use in pharmaceutical analysis by NIR spectroscopy.

M Blanco1, M Bautista, M Alcalá

  • 1Department of Chemistry, Analytical Chemistry Unit, Faculty of Sciences, Autonomous University of Barcelona, E-08193 Bellaterra, Spain. marcel.blanco@uab.es

Journal of Pharmaceutical Sciences
|August 4, 2007
PubMed
Summary

A novel method uses lab samples mimicking production variability to create robust calibration models without reference values. This approach simplifies pharmaceutical analysis using Near-Infrared (NIR) spectroscopy and Process Analytical Technology (PAT).

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Area of Science:

  • Analytical Chemistry
  • Pharmaceutical Science
  • Process Analytical Technology (PAT)

Background:

  • Conventional calibration methods often rely on reference values obtained through complex reference methods.
  • These methods can be time-consuming and may not fully capture the variability present in actual production samples.
  • Developing robust and simplified calibration models is crucial for efficient pharmaceutical manufacturing.

Purpose of the Study:

  • To develop a new methodology for constructing calibration sets using laboratory samples that replicate production variability.
  • To create simpler, more robust calibration models for quantifying active pharmaceutical ingredients (APIs) in pharmaceutical granulates.
  • To explore the potential of Near-Infrared (NIR) spectroscopy as an absolute analytical method within Process Analytical Technology (PAT).

Main Methods:

  • Development of a methodology using laboratory samples subjected to granulation to mimic production variability.
  • Construction of partial least squares (PLS1) calibration models using these laboratory samples.
  • Application of the multiplicative curve resolution-alternating least squares (MCR-ALS) algorithm to investigate API polymorphic transformations during granulation.

Main Results:

  • The proposed methodology successfully generated robust calibration models without requiring reference values.
  • Near-Infrared (NIR) spectroscopy proved effective for API quantification, serving as a viable alternative to traditional reference methods.
  • The MCR-ALS analysis provided insights into potential polymorphic transformations of the API during the granulation process.

Conclusions:

  • The developed methodology offers a simpler and more robust approach to calibration model construction in pharmaceutical analysis.
  • NIR spectroscopy, when used with this methodology, functions as an absolute analytical method, aligning with Process Analytical Technology (PAT) principles.
  • This approach enhances the efficiency and reliability of API quantification and process understanding in pharmaceutical manufacturing.