MTS Helpdesk Question: Is the limit of quanitation always important when validating methods for impurities? Answer: Defined as “the lowest amount of analyte in a sample which can be quantitatively determined with suitable precision and accuracy” in ICH Q2, limit of quantitation (or ‘quantitation limit’ in the ICH terminology) is an important method performance characteristic […]
Category: Articles
How Long to Equlibrate an HPLC Column?
MTS Helpdesk Question: How long does it take to equilibrate a column on an HPLC system before the first injection can be performed? Answer: This is a question commonly asked by HPLC analysts, particularly those relatively new to the technique. The range of currently available column dimensions means that a ‘one size fits all’ approach […]
Replicates in Analytical Methods: When and How Many?
MTS Helpdesk Question: What is the purpose of preparing replicates in analytical methods? Answer: Do you prepare your samples/standards in duplicate without really thinking about it? If challenged on why, would your answer be something like, “it’s good practice, isn’t it?” The use of replicates in analytical procedures is commonplace but it is important to […]
HPLC Autosampler Vials: Dos and Don’ts
MTS Helpdesk Question: Can you provide some dos and don’ts related to HPLC vials? Answer: The HPLC vial is a seemingly minor component of an HPLC system but it has the potential to create major problems. This is particularly true for quantitative analysis. The following list of dos and don’ts will help you to avoid […]
A Brief Guide to HPLC Instruments
High Performance Liquid Chromatography, or HPLC as it is commonly known, is an important analytical technique used to gain both quantitative and qualitative data for samples produced in a variety of industries such as pharmaceuticals, food products and industrial chemicals. The purpose of this video is to look at the question: ‘What is an HPLC […]
Why are ‘Bio’ Test Methods so Tricky to Validate?
MTS Helpdesk Question: When it comes to validation, analytical test methods used for medicinal products based on biological molecules can be a bit ‘tricky’ to deal with. Coming up with a suitable design for the validation protocol can be quite difficult. In particular, the choice of what parameters to investigate, and the design of the […]