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Pharma Discipline
FDCA Form 37 Approved21 CFR Part 11 Compliant
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Stability Studies

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

ICH Q1AAcceleratedReal-TimeShelf Life
Study DurationUp to 36 months (real-time)
Chamber Capacity10,000+ samples
Monitoring24/7 automated alerts
Zones CoveredICH Zone I, II, III, IVA, IVB
● Lab Capacity ActiveForm 37 Certified

Study Protocol Support

Direct access to analytical specialists for study design, method validation, and turnaround timelines.

Submit Sample MatrixDownload Service Spec Sheet
Direct Technical Desk:+91 76240 54108
Service Scope & Regulatory Framework

Rigorous Scientific Execution Built for Global Regulatory Dossiers

Jarvogen 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.

Compendial Standards & Regulatory Alignment:
✓ ICH Q1A(R2)✓ ICH Q1B✓ ICH Q1C✓ ICH Q1E✓ ICH Q5C
Dual-Analyst Review

100% 4-eye verification of all chromatograms, integrations, and calculations before CoA generation.

ALCOA+ Data Integrity

Direct electronic data capture with immutable audit trails, restricted rights, and disaster backups.

Technical SpecificationscGLP Compliant

Study DurationUp to 36 months (real-time)
Chamber Capacity10,000+ samples
Monitoring24/7 automated alerts
Zones CoveredICH Zone I, II, III, IVA, IVB
Quality Credentials
FDCA Gujarat Form 37ICH Compliant (Q1–Q14)21 CFR Part 11
Key Analytical Capabilities

What's Covered in the Testing Scope

Comprehensive assay, stability, and characterization endpoints validated to global pharmacopoeial standards.

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Long-term stability (25°C/60% RH, 30°C/65% RH)Executed with validated SOPs and full raw data audit trails.
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Accelerated stability (40°C/75% RH)Executed with validated SOPs and full raw data audit trails.
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Intermediate stability (30°C/65% RH)Executed with validated SOPs and full raw data audit trails.
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Stress/forced degradation studiesExecuted with validated SOPs and full raw data audit trails.
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Photostability (ICH Q1B)Executed with validated SOPs and full raw data audit trails.
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Freeze-thaw cycling studiesExecuted with validated SOPs and full raw data audit trails.
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In-use stability studiesExecuted with validated SOPs and full raw data audit trails.
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Shelf-life prediction and statistical analysisExecuted with validated SOPs and full raw data audit trails.
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24/7 chamber monitoring with LIMS integrationExecuted with validated SOPs and full raw data audit trails.
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Regulatory submission-ready reportsExecuted with validated SOPs and full raw data audit trails.
Qualified Laboratory Infrastructure

Validated Instrumentation & Data Systems

All instruments operate with full IQ/OQ/PQ qualification, automated audit trails, and 21 CFR Part 11 software packages.

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ICH Stability Chambers (Zone I–IVB)

Long-term, accelerated, intermediate storage

IQ/OQ/PQ QualifiedALCOA+ Audit Trail
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HPLC (UV/PDA)

Assay and degradation product analysis

IQ/OQ/PQ QualifiedALCOA+ Audit Trail
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GC-FID

Residual solvent monitoring during stability

IQ/OQ/PQ QualifiedALCOA+ Audit Trail
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UV-Vis Spectrophotometer

Appearance and color change monitoring

IQ/OQ/PQ QualifiedALCOA+ Audit Trail
Study Execution Lifecycle

How We Execute Your Study

Standardized 4-stage laboratory workflow ensuring traceability from sample intake to CoA release.

01
Stage 01

Protocol Preparation

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

02
Stage 02

Sample Placement

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

03
Stage 03

Interval Testing

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

04
Stage 04

Trend Analysis & Report

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

Scientific Questions & Answers

Technical FAQs

Standard testing is delivered in Up to 36 months (real-time). Expedited priority slots are available upon request with dedicated instrument reservations and expedited QC review.
Ready for Sample Testing?

Initiate Your Stability Studies Study

Submit your sample matrix or request a pre-study analytical protocol discussion with our senior scientists today.

Schedule Scientific Consultation
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