The pharmaceutical industry requires precise and reliable analysers to guarantee drug safety
Pharmaceutical analysis provides valuable information on the identity, purity, content, and stability of raw materials, excipients, and active pharmaceutical ingredients (API).
Metrohm provides top-quality analytical instruments, know-how, and first-class on-site service to enable and support your production of pharmaceutical products.
Our software ensures peace of mind with FDA 21 CFR Part 11 and EudraLex, Volume 4, Annex 11 compliance, long-term support, and global client-server networks.
Download this White Paper to learn more about how ion chromatography supports pharmaceutical analysis as well as its integration into the USP.
Metrohm offers robust analytical solutions to support quality control, method validation, and compliance with global pharmacopeias such as USP, EP, and JP.
All-in-one potentiometric autotitrator platform: faster results, safer handling of chemicals, and maximum modularity for easier adaptability to your requirements.
The new benchmark in ion chromatography
Good vibes in your lab: State-of-the-art near-infrared spectrometer for easier, faster, and more efficient quality control and routine screening.
The total iron content as well as the distribution of Fe(II) and Fe(III) are critical quality attributes for iron citrate. Conventional techniques such as ICP and mass spectrometry do not directly distinguish iron species without additional sample preparation. This study shows how voltammetry enables direct, selective quantification of Fe(II) and Fe(III) in citrate matrices, while standard addition compensates for matrix effects to ensure reliable results.
Stearic acid and stearate derivatives are produced through multistep processing and require monitoring of key quality attributes, including iodine value, acid value, moisture, ash content, melting point, and granulometry. This study demonstrates that near-infrared (NIR) spectroscopy with the OMNIS NIR Analyzer enables rapid, nondestructive quantitative analysis of these parameters for both in-process and final-product samples.
Low frequency Raman spectroscopy extends conventional Raman analysis by capturing vibrational modes down to 65 cm-1, enabling deeper insights into molecular structure, protein characterization, polymorph identification, and phase changes.
The objective of validation of an analytical procedure is to demonstrate that it is suitable for its intended purpose. Recommendations for the validation of analytical methods can be found in ICH Guidance Q2(R1) Validation of Analytical Procedures: Text and Methodology and in USP General Chapter <1225> Validation of Compendial Procedures. The goal of this white paper is to provide some recommendations for the validation of titration methods.
This white paper summarizes the steps involved in converting an existing manual titration procedure to semi-automated or automated titration procedures. It discusses topics such as selecting the right electrode and titration mode. For a better understanding, the discussion topics are illustrated with three examples.
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