Blog
Forced Degradation (1) HPLC (7) ICH (9) Lifecycle (4) Method development (1) Methods (1) MTS (2) MTS Helpdesk (4) OOS/OOT (1) Procedures (1) Stability (3) Troubleshooting (1) Validation (13) Video (4) Webinar (2)
-
What is Mass Balance in a Forced Degradation Study?
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. A method…
-
Why are ‘Bio’ Test Methods so Tricky to Validate?
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 associated experiments. One…
-
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…
-
2022 Course Calendar
Our schedule of courses for 2022 is now available for you to download as a pdf, just click on the image in this post. The document is interactive and you can click on the course titles to access course information, and on the ‘Book Now’ buttons if you’re ready to make a booking. Contact us…
-
A Wish List for ICH Q2(R2), the Revision of the Guideline on Method Validation
The ICH guideline on method validation, Q2 (R1) [1], is currently being updated and I thought it might be interesting to put together a wish list for the changes that I would like to see in the new version. Rather than a wide-ranging treatment of all analytical method validation related issues, such as how it…
Forced Degradation (1) HPLC (7) ICH (9) Lifecycle (4) Method development (1) Methods (1) MTS (2) MTS Helpdesk (4) OOS/OOT (1) Procedures (1) Stability (3) Troubleshooting (1) Validation (13) Video (4) Webinar (2)