Analytical Laboratory What Not To Do – Post 1

This pharmaceutical scientist has just returned from a week in Europe.  Returning to work on a Friday has spurred some less topical laboratory ranting. Over my 20 years of lab experience (wow…), I have seen many “interesting” techniques in the lab.  Take this as the start of a list of What Not to Do in a Lab posts that will be posted occasionally   Let me also point out that these were...

Read More

Analytical Method Authoring: Ensure that your Method is User Friendly for Quality Control- Part 3

In parts 1 & 2 of this blog post, I wrote about ways to make sure that the HPLC analytical method that you are developing is user friendly for the QC laboratory that will be performing the drug substance or drug product release.  I am focusing on methods required for release of Phase 1 or Phase 2 clinical trial materials.  Many of these items are also helpful for non-QC labs that receive...

Read More

Developing a Stability-Indicating Method: Forced Degradation

At Velesco, we are occasionally asked to explain the process of developing a stability-indicating HPLC method.  One very important step in determining whether a method is stability-indicating is to perform Forced Degradation experiments.  Here, I will explain these experiments and how we approach the process. It’s important to challenge your analytical method for its ability to accurately...

Read More

Analytical Method Authoring: Ensure that your Method is User Friendly for Quality Control- Part 2

In part 1 of this blog post, I wrote about ways to make sure that the HPLC analytical method that you are developing is user friendly for the QC laboratory that will be performing the drug substance or drug product release.  I am focusing on methods required for release of Phase 1 or Phase 2 clinical trial materials.  Many of these items are also helpful for non-QC labs that receive the...

Read More

Analytical Method Authoring: Ensure that your Method is User Friendly for Quality Control- Part 1

As an HPLC analytical method development veteran, I know that we all have a way that we like to write methods that make sense to ourselves.  However, it’s very important to keep the end user of your “product”, the method, in mind.    Since methods have quite a few sections, I will discuss this over several blog posts, targeting methods validated for Phase 1 and Phase 2. It’s important...

Read More