HPLC Validation - Stability Indicating Methodology Explained, SME Michael Dong, PhD.

Solid paper written by a SME in pharmaceutical analysis, he has a deep understanding on the validation process as it applies to the pharmaceutical industry - in addition stability indicating methodology is a critical step in drug development. LCGC just published this very applicable whitepaper. It was invited to help review and edit, it was so well written I didn’t have much to contribute or change. Although Pharma focused a lot of the information can be applied to other industries.

https://www.linkedin.com/feed/update/urn:li:activity:6731575101592100865/?commentUrn=urn%3Ali%3Acomment%3A(ugcPost%3A6731575101067812864%2C6731593338471911425)

Some takeaways from this paper- include the following on method robustness:

https://cdn.sanity.io/files/0vv8moc6/chroma/3a1fcc45168e578e63bd2393ff21c037ac7854b9.pdf. (available free on LCGC Website)

Typical parameters that can be adopted for any HPLC method being developed and evaluated for robustness. Definitely including solution stability- CRM-certified reference materials and over a course of study period- i.e. 7 days solution stability (sa…

Typical parameters that can be adopted for any HPLC method being developed and evaluated for robustness. Definitely including solution stability- CRM-certified reference materials and over a course of study period- i.e. 7 days solution stability (sample).