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© 2021 MJH Life Sciences and Chromatography Online. All rights reserved.
© 2021 MJH Life Sciences™ and Chromatography Online. All rights reserved.
November 01, 2020
In the pharmaceutical industry, method validation is essential. But what are the best practices? We review regulatory requirements, validation parameters, methodologies, acceptance criteria, trends, and software tools.
August 01, 2020
Here we provide an overview of the fundamentals and best practices on the development of stability-indicating HPLC methods for drug substances and products. We explain both traditional and easier modern approaches to developing stability-indicating HPLC methods—including using a universal generic method for new chemical entities—and address regulatory considerations and life cycle management strategies.
June 01, 2020
Determining product shelf life is a regulatory requirement for pharmaceuticals and many other regulated consumer products. In this comprehensive overview of stability studies and testing, we summarize current regulatory requirements, share industry practices for forced degradation, and explain approaches for reduced testing and data evaluation to expedite stability study timelines.
May 01, 2020
A fast ultrahigh-pressure liquid chromatography (UHPLC) method, with low solvent consumption, is described for the determination of coenzyme Q10 in a variety of complex formulations. This method exhibits good linearity, reproducibility, accuracy, recovery, and specificity, while resulting in an acceptable limit of detection (LOD) and limit of quantification (LOQ).
March 01, 2020
This article will discuss the benefits of 2D-LC and multiple application areas in (bio)pharmaceutical analysis, and will highlight the challenges and future outlook.
December 01, 2019
This article presents possible uses of ion chromatography and related techniques combined with various detection methods for clinical and pharmaceutical analysis of common inorganic and organic anions and cations. An overview of achievements in this area from the past 10 years is presented and the most important trends and development perspectives for ion chromatography are described.
July 01, 2019
The main objective of this review article is to provide a clear summary of the different methods that can be used to quantify endogenous small molecules. Because of the increased use of mass spectrometry (MS) in the field of bioanalysis, a special focus will be placed on quantification by liquid chromatography (LC)–MS. Practical recommendations to face this bioanalytical challenge, in particular in terms of method validation, will also be provided.
June 01, 2019
The European Pharmacopoeia (Ph. Eur.) defi nes requirements for the qualitative and quantitative composition of medicines, as well as the tests to be carried out on medicines and on substances and materials used in their production.
May 08, 2019
This article focuses on ways to accelerate glycan screening data analysis, while keeping high reproducibility.A major focus of the pharmaceutical industry is the production and development of biologics-therapeutics produced via biological means-to provide novel treatments for diseases with unmet clinical needs. A large percentage of biologics under development are proteins, such as monoclonal antibodies (mAbs), fusion proteins, antibody–drug conjugates (ADCs), and enzymes. The structures of these protein drugs are made more complex by post‑translational modifications (PTMs).