Rapid QC Tablet Testing with Transmission Raman Spectroscopy

The Agilent TRS100 Raman system is ideal for fast assay of tablets, capsules, and other dosage forms. Transmission Raman technology from Agilent enables simple method-development and deployment in QC applications. It is easy to implement in analytical laboratories and production areas, and has regulatory approvals for content uniformity (CU), assay, and identification (ID) applications. This online seminar provides a comprehensive introduction to the Transmission Raman technology and the Agilent TRS100 Raman system in the pharmaceutical quality-control applications.

 

Speakers

Yanqia Wang, PhD, Application Engineer, Molecular Spectroscopy, Agilent Technologies, Inc.

Dr. Yanqia Wang started working for Agilent Technologies Inc. as a FTIR application Engineer in 2013, providing pre-&post-sale application support. The products he covers from Bench-top FTIR microscopes to various Mobile FTIR spectrometers. Dr. Wang received his PhD of analytical chemistry from Duke University in 2004, doing dynamic IR spectroscopy research. Then he joined Fitzpatrick Center for Photonics at Duke University, doing Tissue Raman spectrometer instrumentation. Since 2007, Dr. Wang worked for Avery Dennison Corp. as a spectroscopist, providing molecular analytical support to the research & development.

 

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Quality Control | Dissolution Testing

Drug dissolution testing provides necessary in vitro drug release information for pharmaceutical manufacturing quality control, making it a critical tool for performance characterization of diverse dosage forms. Agilent offers pharmaceutical dissolution testing products for product formulation and other applications.

 

Resources

Merits of Automated Sampling in Dissolution Testing

Technical Overview

Dissolution Systems Source Book

Catalogue

Quality Control | Residual Solvent Testing

Residual solvent impurities in pharmaceuticals are trace amounts of volatile organic compounds used in drug production that remain in the final drug product. Strict regulations require close monitoring on the presence of residual solvent, as even trace amounts can impact drug safety and efficacy.

 

Resources

Satisfy Requirements for Residual Solvent Analysis

Brochure

Residual Solvents Analysis Using an Agilent Intuvo 9000 GC with 8697 Headspace Sampler

Application Note

Analysis of USP Method <467> 

Application Note

Quality Control | Elemental Impurities

With increasing awareness of the potential harmful effects of inorganic contaminants, regulatory organizations have provided new guidelines recommending analytical techniques, such as ICP-OES and ICP-MS, to monitor elemental impurities. Agilent offers integrated solution for confident elemental impurities testing.

 

Resources

USP <232>/<233> and ICH Q3D Elemental Impurities Analysis by ICP-OES

Application Note

USP <232>/<233> and ICH Q3D Elemental Impurities Analysis: Agilent’s ICP-MS solution

White Paper

Support for 21 CFR Part 11 and Annex 11 Compliance: SDA Module for Agilent ICP-MS MassHunter Software

White Paper

Simplified QC for Pharmaceutical Elemental Impurity Analysis

Overview

Quality Control | Nitrosamine Mutagenic Impurities

Several drug products were recently recalled due to the presence of unacceptable amounts of mutagenic nitrosamine impurities. Chemetrix offers relevant GC/MS, LC/MS and high-throughput MS-based analytical technologies to accurately detect and quantify trace mutagenic and genotoxic impurities in drug products.

 

Resources

Nitrosamine Impurities Application Guide

Application Guide

Determination of Nitrosamine Impurities Using the Ultivo Triple Quadrupole LC/MS

Application Note

Quantification of Nitrosamine Impurities in Metformin Using Agilent GC/MS/MS Instrumentation

Application Note

Determine Nitrosamines Using LC/MS in Metformin-Based Drugs

Application Note

Determination of a Genotoxic NDMA Impurity Using the High-Resolution Agilent 6546 LC/Q-TOF in Ranitidine

Application Note

Quality Control | Extractables & Leachables

Extractables and leachables (E&Ls) analysis is challenging and requires complete confidence in the results to ensure regulatory compliance. No single analytical tool can analyze all E&Ls; we offer diverse analytical technologies and expertise for the accurate identification and quantification of potential E&Ls.

 

Resources

Analysis of Extractable/Leachable Compounds from Generic Liquid Drug Formulations Using GC/MSD Systems

Application Note

Analysis of Extractable and Leachable (E&L) Compounds Using a Low-Energy EI-Capable High-Resolution Accurate Mass GC/Q-TOF

Application Brief