GMP & Regulatory
Impurity limits, analytical helpers, and quality-document drafts with cited primary sources. Verify against the current guideline text.
Impurity limits
4 tools- GMP · IMPURITY LIMITS
Nitrosamine Limit
CPCA category, AI to ppm, multiple nitrosamines, and ICH M7 classes, TTC, and LTL.
out: Cat · ppm · Σ AI · µg/dayOpen → - GMP · IMPURITY LIMITS
Residual Solvent Limit
ICH Q3C Tables 1–4, Option 1, Option 2, and Option 2 summation.
out: ppm · PDE · PASS/FAILOpen → - GMP · IMPURITY LIMITS
Elemental Impurity Limit
ICH Q3D PDEs with Option 1, Option 2a, and Option 2b component summation.
out: µg/g · µg/day · PASS/FAILOpen → - GMP · IMPURITY LIMITS
E&L AET
ICH Q3E draft AET from SCT, UF, and worst-case dosing for E&L studies.
out: µg/component · µg/g · µg/mL · µg/cm²Open →