ICH Q1A(R2) Stability Diagnostics (Extended 24-Month Studies)

Service Description

Extends standard 12-week accelerated stability into an exhaustive 24-month real-time stability program in precision-controlled climatic chambers (ICH Climatic Zone IVb). Includes structured analytical testing intervals tracking physical appearance, active assay potency, viscosity drift, and microbiological safety required for multi-year expiration dating. Lead Time: 24 Months Who is this service for: Pharmaceutical brands, mass pharmacy retail brands requiring formal 2-to-3-year expiration dates. What this service adds to your product/offering: Validates 2- to 3-year commercial shelf-life warranties; mandatory for listing in major pharmaceutical retail chains.