Cooling vs antisolvent crystallization: how supersaturation is generated, when cooling simply cannot work, and a worked example: 0.0% vs 99.96%.
June 28, 2026
Insights
Insights
Articles for analytical, QC and CMC teams: spectra, impurities, stability, ICH M7 and HPLC, each with a worked example.
All articles
Comparison8 min read
Cooling vs Antisolvent: Choosing the Isolation Route
Guide8 min read
PDE vs TTC in Cleaning Validation: The Genotoxic Case
PDE vs TTC cleaning validation: when a health-based PDE applies, when ICH M7 forces the 1.5 µg/day TTC, and how to check the residue is even cleanable.
June 25, 2026
Explainer7 min read
Significant Change Under ICH Q1A: What Triggers It
Significant change ICH Q1A explained: the exact assay, degradant, dissolution and physical triggers, and what intermediate testing you owe once it fires.
June 25, 2026
Explainer8 min read
Design Space, NOR and PAR: ICH Q8 Explained
ICH Q8 design space, NOR and PAR defined precisely, with real worked results showing what a tighter spec costs you in operating window.
June 24, 2026
Use case8 min read
Nitrosamine Risk Assessment: An ICH M7 Workflow
A practical nitrosamine risk assessment workflow for NDSRIs: ICH M7 dual assessment, real classifications, and where the QSAR goes out of domain.
June 24, 2026
Guide8 min read
Extractables and Leachables: A Screening Workflow
A structure-first extractables leachables screening workflow: match peaks to known additives, set the AET, then hand structures to toxicological triage.
June 23, 2026
Guide8 min read
Planning a Forced Degradation Study under ICH Q1A(R2)
Forced degradation study design under ICH Q1A(R2): stressor choice, target degradation, mass balance and stability-indicating methods, with real results.
June 19, 2026
Guide8 min read
pH-Solubility Profiles and Salt Selection
How to build a pH solubility profile for salt selection, with real numbers on ibuprofen, and where Henderson-Hasselbalch stops being true.
June 19, 2026
Explainer8 min read
Applicability Domain in QSAR: When a Model Says I Don't Know
What the applicability domain in QSAR is, how Tanimoto, feature range and leverage methods define it, and why out-of-domain predictions must be downgraded.
June 14, 2026
Use case7 min read
Green Solvent Substitution Without Losing Solubility
Green solvent replacement in pharma: rank ICH Q3C Class 3 alternatives to DCM and chloroform by predicted solubility before you book lab time.
June 13, 2026
Guide8 min read
Solvent Selection Under ICH Q3C: A Data Question
Solvent selection under ICH Q3C explained: what Class 1, 2 and 3 mean, the ppm limits, and how predicted solubility narrows the candidate list before lab.
June 13, 2026
Explainer8 min read
Binding Site Druggability Prediction, Honestly Read
Binding site druggability prediction explained: how geometric pocket detection works, what the score means, and a real assessment of KRAS G12C.
June 9, 2026
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