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Revised ISO guideline highlights toxicological evaluation of extractables and...

In the guideline published in 2023, the process and requirements for toxicological risk assessment of medical device constituents is outlined. Also covered in the guideline are “the methods and...

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Biosensing technique promising for whole-genome detection

A study has described a multivalent-colloid detection system capable of identifying whole genomes of bacteria without the use of DNA amplification. Data from the paper published in Applied Physical...

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Raman and machine learning show promise for online monitoring of bioreactors

Researchers based in France have demonstrated a robust online Raman monitoring model for bioreactors, which combines Raman spectroscopy and machine learning (ML). In the study, the fermentation of...

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Nelson Labs facility expansion to benefit parenteral and ophthalmic drug...

The investment… includes state-of-the-art instrumentation to provide full CMC support to serve the growth of PODP [manufacturers]” Nelson Labs, a global leader in microbiological and analytical...

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Forward-thinking CDMO tackles the dynamic challenge of N-nitrosamines control...

Register your details to discover more about meeting global nitrosamine requirements, LC-MS/MS for identification and quantification of nitrosamines and how you can adapt to evolving trends. API...

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Analytical technique may advance medical cannabis quality control

Researchers have proposed an advanced analytical technology that can rapidly classify medical cannabis plants at production sites. Using the analytical technique, the plants can be classified “by...

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Validation of analytical procedures – ICH Q2(R2)

After almost two decades, ICH Q21 (validation of analytical procedures) has finally been updated and now includes more recent analytical applications, which are non‑chromatographic in nature, eg,...

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Coherent Raman scattering microscopy: a powerful tool for pharmaceutics

Chemometric optical microscopy techniques provide numerous opportunities for the pharmaceutic industry, both in the manufacturing stage and in R&D for drug discovery and development. One valuable...

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Using mass spectrometry to improve quality and safety of levothyroxine

In investigating formulations of the hypothyroidism drug levothyroxine, researchers have developed a new non-targeted approach using ultra-high-performance liquid chromatography with a data-independent...

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Safeguarding purity under pressure: detecting nitrosamine contamination

In 2018 the discovery of unacceptable levels of N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) in angiotensin receptor blockers (ARBs) triggered increased regulatory focus on...

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European Pharmaceutical Review Issue 2 2024

Articles included in Issue 2 of European Pharmaceutical Review – our cell and gene therapy focus – include: CELL & GENE THERAPY Proper planning prevents CMC disasters for cell and gene therapies...

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Guide to Testing 2024

LoD requirements of qualitative microbiological methods for short shelf-life products In this article, Edwin van den Heuvel from Eindhoven University of Technology and MSD’s Pieta Boon investigate the...

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Application of NGS to enhance the molecular monitoring of CML patients

ICON has developed a novel RNA-based Next Generation Sequencing (NGS) assay that supports more accurate monitoring of chronic myeloid leukemia patients. Here we discuss its benefits over standard NGS...

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Accelerating spectroscopic analysis for data acquisition

Researchers in Germany have developed an technique to increase the speed of spectroscopic analysis, which typically takes from minutes to hours to acquire measurement. [the technique] can greatly...

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Advancements and knowledge gaps in ICH Q2(R2)

The landscape of scientific and technological advancements has evolved significantly since the finalisation of the first version of ICH Q2 in the 1990s. Particularly notable is the progress in advanced...

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Sustainable RP-HPLC method for simultaneous determination of hypertension drugs

Researchers have demonstrated a reverse phase-high performance liquid chromatography (RP-HPLC) method for the simultaneous determination of Amlodipine and Irbesartan using analytical quality by design...

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Technology innovation aiding process spectroscopy market growth

A report by Spherical Insights has predicted that the process spectroscopy market will value $35.8 billion by 2033. Process spectroscopy is becoming more connected to automation and digitalisation...

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Analysis of chiral compounds using supercritical fluid chromatography

A study comparing sub/supercritical fluid chromatography (SFC) to normal phase high-performance liquid chromatography (NP HPLC) has reported that amylose tris (3‑chloro-5-methylphenylcarbamate)-based...

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SFC-MS: advancements and applications in pharmaceutical quality control

Pharmaceutical quality control (QC) is an essential aspect of the pharmaceutical industry, ensuring that medicinal products meet the desired quality standards and comply with regulatory requirements....

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Optimising reverse-phase chromatography for molnupiravir production

Research indicates that optimising column length and flowrate is essential for achieving desired separation efficiency and resolution when working to gain optimal chromatographic separation, research...

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