§ Insights
Insights
Method notes, regulatory updates, and analytical case studies from the lab.
- 2026 · 06Method note
TFA counter-ion correction for peptide net-mass reporting
Why an apparently 99%-pure peptide can be 15% counter-ion by mass — and what that means for dose calculation and CoA reporting.
IN-04 · 6 min readRead - 2026 · 05Regulatory
ICH Q3D(R2) revisions and what changed for oral solid dosage forms
A concise reader for QA teams: what moved between classes, what the new PDEs are, and which risk assessments now need revisiting.
IN-03 · 8 min readRead - 2026 · 04Case study
Anonymised: three CDMO transitions and the assays that flagged them
What second-source verification found on three separate CDMO-transition batches — and how the client used the data.
IN-02 · 5 min readRead - 2026 · 02Method note
Setting up MS/MS sequence-confirmation with high b/y-ion coverage
Practical LC-MS/MS acquisition parameters for peptides up to 5 kDa, with worked examples on tirzepatide and BPC-157.
IN-01 · 10 min readRead
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