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Forced degradation & stability-indicating methods

In short

Forced degradation per ICH Q1A(R2) stresses the active under acid, base, oxidation (H₂O₂), thermal, humidity and photolytic (ICH Q1B Option 1 or 2) conditions to generate degradants. A stability-indicating method is then validated under ICH Q2(R2) to resolve and quantify those...

Forced degradation per ICH Q1A(R2) stresses the active under acid, base, oxidation (H₂O₂), thermal, humidity and photolytic (ICH Q1B Option 1 or 2) conditions to generate degradants. A stability-indicating method is then validated under ICH Q2(R2) to resolve and quantify those degradants — without which a stability claim is unsupported. Most supplement actives that fail late-stage stability fail because the assay was potency-only, not stability-indicating.

Regulatory anchors
  • ICH Q1A(R2)
  • ICH Q1B
  • ICH Q2(R2)
How V5 handles it
QMS — quality records next to the work they concern.
Deviations, corrective actions and quality review sit in the same system as production, so each quality record references the work order, step and lot it concerns.
Document control — one version in force, every change signed and explained.
Draft the next revision while the current one stays in use, approve it under your sign-off route, and track training on it — with the history kept.
Related terms
Reference standard qualificationSupplement Stability & Shelf Life
Software that covers Forced degradation & stability-indicating methods
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