Application note: Comprehensive fractionation of herbal medicine components by PDA-ELSD-triggered preparative LC
This article introduces a comprehensive fractionation method for both UV absorbing and non-UV absorbing compounds.
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This article introduces a comprehensive fractionation method for both UV absorbing and non-UV absorbing compounds.
The valsartan nitrosamine contamination issue was probably the most significant quality issue to hit the pharmaceutical industry in a decade. Here, Dave Elder outlines how agencies and manufacturers are dealing with the problem and indicates the knowledge gaps that might be concealing future complications.
Here, Dave Elder discusses the determination of less than lifetime (LTL) limits for highly potent N-nitrosamine compounds and how to ensure safety in dosing.
Host cell protein-automated iterative mass spectrometry (HCP-AIMS) enables the robust, reproducible and high throughput analysis of host cell proteins, says study.
Experts suggest membrane-based technologies could become a vital component in end-to-end intensified bioprocesses for monoclonal antibodies.
A Class 2 recall notice for one batch of Rosemont Pharmaceuticals metformin hydrochloride 500mg/5ml oral solution has been issued by the MHRA.
The function of a pharmaceutical drug product or a medical device is to provide the patient with a desired therapeutic benefit.
Timelines for assessing the potential for contamination of medicinal compounds with nitrosamines have been revised. Here, Dave Elder explains the EMA’s and FDA’s positions and the likely scenarios to be encountered.
Nelson Labs is the leading global extractables and leachables lab testing platform, in this guide find out about their other services and how, from development to delivery, they can help get your products to market.
The new general chapter (2.5.42) outlines three procedures for the analysis of N-nitrosamine impurities in active substances.
The European Medicines Agency committee reports its November findings, including five drugs recommended for marketing authorisation.
Product recalls due to contamination issues can be extremely costly for companies, in addition to the associated health implications. In this article, Marc Baiget Francesch explores the potential risks associated with N-nitrosodimethylamine (NDMA) contamination, why is it such a frequent contaminant and how to detect and eliminate the risks.
Included in this in-depth focus is a discussion on how to detect and eliminate NDMA impurities in medicines and an article exploring the complexities of sterility assurance, providing manufacturers with guidance.
Within this issue find articles on the complexities of sterility assurance, how to detect and eliminate the risk of NDMA contamination and the findings from a study involving a novel formulation of cannabinoids that has been developed to treat glioblastoma. Also included are articles on the opportunities blockchain provides for…
The agency’s opinion will require companies to take measures to reduce nitrosamine impurities in medicines and carry out and action the results of risk assessments.