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Related Concept Videos

Raman Spectroscopy Instrumentation: Overview01:26

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A conventional Raman spectrophotometer includes a laser source, a sample holding system, a wavelength selector, and a detector.
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An analytical methodology can be divided into four sequential steps: technique, method, procedure, and protocol. A technique is a scientific principle that rationalizes a specific phenomenon through chemical measurements. Adapting a technique for analyzing a sample of interest is termed a method. The procedure outlines the directions for performing the analysis via an analytical method. The protocol is the detailed guidelines on the procedure, which should be strictly followed to obtain the...
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Compendial dissolution methods are standardized procedures defined by pharmacopeias to evaluate the rate at which a drug dissolves in a specific medium. These methods ensure batch-to-batch consistency, enable quality control, and support the prediction of drug bioavailability. They are critical for both immediate and modified-release drug products.The apparatuses used for dissolution testing differ in their design and mechanical function, but all aim to simulate the physiological environment of...
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Therapeutic Drug Monitoring (TDM) is a clinical practice that measures specific drug levels in a patient's blood or body tissues to tailor drug therapy effectively. This monitoring is critical for managing drugs with narrow therapeutic indices like digoxin and phenytoin, ensuring they are both safe and effective. For instance, monitoring theophylline levels in asthma patients involves precision and sensitivity to adjust doses according to individual responses to therapy, ensuring efficacy and...
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Method validation is a crucial process in analytical chemistry designed to confirm that a given method consistently produces reliable and high-quality results. This process is essential when a method is applied to different sample matrices or when procedural modifications are made, ensuring that the results meet acceptable standards across various applications.
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Related Experiment Video

Updated: Mar 28, 2026

Coherent anti-Stokes Raman Scattering CARS Microscopy Visualizes Pharmaceutical Tablets During Dissolution
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Method development and validation for pharmaceutical tablets analysis using transmission Raman spectroscopy.

Yi Li1, Benoît Igne2, James K Drennen3

  • 1Graduate School of Pharmaceutical Sciences, Duquesne University, 600 Forbes Avenue, Pittsburgh, PA 15282, United States.

International Journal of Pharmaceutics
|December 15, 2015
PubMed
Summary
This summary is machine-generated.

This study developed and validated a rapid transmission Raman spectroscopy method for quantifying niacinamide in tablets. The validated method offers fast analysis times and is suitable for routine quality control in pharmaceutical manufacturing.

Keywords:
ICH-Q2Stability-indicating assayTransmission Raman spectroscopyValidation

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Area of Science:

  • Analytical Chemistry
  • Pharmaceutical Analysis
  • Spectroscopy

Background:

  • Niacinamide content determination is crucial for pharmaceutical quality control.
  • Traditional methods for content uniformity analysis can be time-consuming.
  • Development of rapid and reliable analytical techniques is essential for efficient drug manufacturing.

Purpose of the Study:

  • To develop and validate a transmission Raman spectroscopic method for niacinamide quantification in tablet cores.
  • To adhere to the International Council for Harmonisation (ICH) Q2 Guidance for method validation.
  • To establish a rapid and accurate method for routine content uniformity analysis.

Main Methods:

  • Utilized transmission Raman spectroscopy for active pharmaceutical ingredient (API) quantification.
  • Employed a 3-level, 2-factor full factorial design to build a partial least-squares (PLS) model.
  • Validated the method based on ICH-Q2 criteria, including linearity, accuracy, precision, and robustness.
  • Assessed method specificity by analyzing niacinamide in the presence of niacin.

Main Results:

  • Successfully developed and validated a transmission Raman spectroscopic method for niacinamide quantification.
  • The method demonstrated excellent linearity, accuracy, precision, and robustness.
  • Method specificity was confirmed, with accurate niacinamide determination in the presence of niacin.
  • Achieved very short analysis times of approximately 2.5 seconds per tablet.

Conclusions:

  • The developed transmission Raman spectroscopic method is fit for purpose for niacinamide content determination in tablets.
  • The method's speed and accuracy make it suitable for routine content uniformity analysis in stability studies.
  • This technique offers a significant advantage in terms of analysis time compared to conventional methods.