Pharma
📊

Stability Studies

ICH-compliant long-term, accelerated, and stressed stability studies with 24/7 monitored climatic chambers.

ICH Q1AAcceleratedReal-TimeShelf Life
Overview

About This Service

AnalytiLab offers comprehensive ICH-compliant stability testing services for pharmaceutical products. Our stability chambers cover all ICH climatic zones (I through IVB) and are equipped with 24/7 temperature and humidity monitoring with automated alerts. We conduct long-term, accelerated, intermediate, and stress stability studies for APIs, drug products, and biological samples.

ICH Q1A(R2)ICH Q1BICH Q1CICH Q1EICH Q5C

Key Information

Study DurationUp to 36 months (real-time)
Chamber Capacity10,000+ samples
Monitoring24/7 automated alerts
Zones CoveredICH Zone I, II, III, IVA, IVB

Accredited by

NABLISO 17025USFDA
Scope of Work

What's Included

Long-term stability (25°C/60% RH, 30°C/65% RH)
Accelerated stability (40°C/75% RH)
Intermediate stability (30°C/65% RH)
Stress/forced degradation studies
Photostability (ICH Q1B)
Freeze-thaw cycling studies
In-use stability studies
Shelf-life prediction and statistical analysis
24/7 chamber monitoring with LIMS integration
Regulatory submission-ready reports
Equipment

Instruments Used

ICH Stability Chambers (Zone I–IVB)

Long-term, accelerated, intermediate storage

HPLC (UV/PDA)

Assay and degradation product analysis

GC-FID

Residual solvent monitoring during stability

UV-Vis Spectrophotometer

Appearance and color change monitoring

Compliance

Regulatory Standards

ICH Q1A(R2)
ICH Q1B
ICH Q1C
ICH Q1E
ICH Q5C
Our Process

How We Work

01

Protocol Preparation

ICH-compliant stability protocol prepared with test parameters, intervals, and acceptance criteria.

02

Sample Placement

Samples placed in appropriate chambers with unique IDs logged in LIMS.

03

Interval Testing

Samples pulled at defined intervals (0, 1, 3, 6, 9, 12, 18, 24 months) and tested.

04

Trend Analysis & Report

Statistical trend analysis performed; shelf-life estimated and final report issued.

Get Started

Ready to Start Your Stability Studies?

Our scientific team is ready to assist. Submit your sample or request a quote today.