Stability Studies & Shelf-Life Protocol Engine
ICH Q1A(R2), WHO Annex 10 & ISO/IEC 17025 Cl. 7.2/7.7 real-time pull schedules, degradation kinetics and 95% confidence shelf-life estimation.
Active Stability Protocols
2
Samples Under Chamber Incubation
39 vials
Pull Timepoints Due This Week
2
Overdue Pulls / Out-of-Window
0
Select Study Protocol:
All pull dates automatically locked to chamber placement timestamp per 21 CFR Part 11.
Study Protocol Specification
Active
Protocol Code
STAB-2025-012
Product / Measurand
Amoxicillin Trihydrate Oral Suspension 250mg/5mL
Lot / Batch Number
LOT-AMX-202509
Dosage Form / Matrix
Dry Powder for Oral Suspension
Container Closure System
Amber Glass Type III Bottle w/ Child-Resistant Cap
Chamber & Conditions
STAB-CHAMBER-02 (40°C/75% RH)
Chamber Placement Date
2026-08-13 09:33 UTC
Assay Specification Limits
90.0% - 120.0%
ICH Q1E Kinetics & Shelf-Life Extrapolation
Expiry: 9 MonthsDegradation Rate (k)
-1.700 %/mo
Linear Fit (R²)
1.0000
Residual Std (s_y/x)
0.000%
Accreditation Verdict: ICH Q1E Lower 95% confidence curve intersects specification (90.0%) at 9 months. Recommended shelf-life: 9 months.
Pull Schedule & Testing Matrix per ICH Q1A(R2)
5 Timepoints| Timepoint | Target Date | Tolerance Window | Status | Pulled At / By | Vials | Assay (%) | Total Impurities (%) | pH | Appearance | Action |
|---|---|---|---|---|---|---|---|---|---|---|
|
T0 (Initial)
Month 0
|
2026-08-13 | 08/13 to 08/13 (±0 d) | Pulled |
Priya Sharma
2026-08-13
|
10 | 104.5% | 0.25% | 5.4 | Free flowing off-white powder | |
|
1 Month
Month 1
|
2026-09-13 | 09/12 to 09/14 (±1 d) | Pulled |
Priya Sharma
2026-09-13
|
10 | 102.8% | 0.42% | 5.3 | Conforms | |
|
2 Months
Month 2
|
2026-10-13 | 10/12 to 10/14 (±1 d) | Pulled |
Priya Sharma
2026-10-13
|
10 | 101.1% | 0.61% | 5.2 | Conforms | |
|
3 Months
Month 3
|
2026-11-13 | 11/11 to 11/15 (±2 d) | Due for Pull | - | - | - | - | - | - | |
|
6 Months
Month 6
|
2027-02-13 | 02/08 to 02/18 (±5 d) | Upcoming | - | - | - | - | - | - |