Stability Studies & Shelf-Life Protocol Engine

Active Stability Protocols

Samples Under Chamber Incubation

39 vials

Pull Timepoints Due This Week

Overdue Pulls / Out-of-Window

Select Study Protocol:

All pull dates automatically locked to chamber placement timestamp per 21 CFR Part 11.

Active

Protocol Code STAB-2025-004

Product / Measurand Paracetamol 500mg Tablets BP

Lot / Batch Number LOT-PCM-202501

Dosage Form / Matrix Solid Oral Dosage (Tablets)

Container Closure System Alu-Alu Blister Pack in Unit Carton

Chamber & Conditions STAB-CHAMBER-01 (25°C/60% RH)

Chamber Placement Date 2025-11-13 09:23 UTC

Assay Specification Limits 90.0% - 105.0%

Expiry: 27 Months

Degradation Rate (k)

-0.387 %/mo

Linear Fit (R²)

0.9997

Residual Std (s_y/x)

0.032%

Accreditation Verdict: ICH Q1E Lower 95% confidence curve intersects specification (90.0%) at 27 months. Recommended shelf-life: 27 months.

8 Timepoints

Timepoint	Target Date	Tolerance Window	Status	Pulled At / By	Vials	Assay (%)	Total Impurities (%)	pH	Appearance
T0 (Initial) Month 0	2025-11-13	11/13 to 11/13 (±0 d)	Pulled	Dr. Rajesh Varma 2025-11-13	6	100.4%	0.08%	6.2	White circular tablets, biconvex, smooth
3 Months Month 3	2026-02-13	02/11 to 02/15 (±2 d)	Pulled	Dr. Rajesh Varma 2026-02-14	6	99.2%	0.12%	6.1	Conforms to initial
6 Months Month 6	2026-05-13	05/08 to 05/18 (±5 d)	Pulled	Dr. Rajesh Varma 2026-05-13	6	98.1%	0.18%	6.1	Conforms to initial
9 Months Month 9	2026-08-13	08/08 to 08/18 (±5 d)	Pulled	Dr. Rajesh Varma 2026-08-12	6	96.9%	0.24%	6.0	Conforms to initial
12 Months Month 12	2026-11-13	11/08 to 11/18 (±5 d)	Due for Pull	-	-	-	-	-	-
18 Months Month 18	2027-05-13	05/03 to 05/23 (±10 d)	Upcoming	-	-	-	-	-	-
24 Months Month 24	2027-11-13	11/03 to 11/23 (±10 d)	Upcoming	-	-	-	-	-	-
36 Months Month 36	2028-11-13	11/03 to 11/23 (±10 d)	Upcoming	-	-	-	-	-	-