Category: Validation

Limit of Quantitation: Does it Matter?

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 […]

Drafts of ICH Q2(R2) and Q14 on Public Consultation

Draft versions of the revision of ICH Q2, Validation of Analytical Procedures, and also the new guideline Q14, Analytical Procedure Development, were published on the 24th March 2022. The deadline for comments is 31st July 2022. You can view the draft guidelines, and also a presentation from ICH about the guidelines, using the following links: […]

How Much Forced Degradation in a Stress Study?

MTS Helpdesk Question: When I forcibly degrade my drug or drug product to create degradation products, how much degradation should I aim for? Answer: The aim of a forced degradation study is to generate degradation products from a drug which are both realistic and representative, typically for the purposes of assessing degradation pathways, or to […]

What is Mass Balance in a Forced Degradation Study?

MTS Helpdesk Question: What is the ‘mass balance’ for an analytical method and is it critical that I investigate it as part of method development or method validation? Answer: When used in the context of an analytical method, the term ‘mass balance’ relates to its ability to analyse the degradation products of a drug molecule. […]

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 […]