Lunar Labs Ltd — GMP contract testing laboratory
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Pharmaceutical Testing

Stability Testing for Pharma Products

ICH Q1A-aligned stability programmes for finished drug products, APIs and dietary supplements. We design the protocol, run the study at controlled conditions, manage pull-points, and deliver dossier-ready reports — at any phase from preclinical through commercial.

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What It Covers

Scope of Work

Long-term stability (25 °C / 60% RH; 30 °C / 65% RH)

Intermediate stability (30 °C / 65% RH)

Accelerated stability (40 °C / 75% RH)

Refrigerated and frozen storage (5 °C, -20 °C, -80 °C)

Photostability per ICH Q1B

Stress / forced-degradation studies (acid, base, oxidation, heat, light)

In-use and in-package stability

Bracketing and matrixing for cost-efficient programmes

How We Do It

Methods & Instrumentation

Stability Chambers

Temperature- and humidity-controlled walk-in and reach-in chambers with continuous monitoring and excursion alarms.

Photostability Cabinet

ICH Q1B Option 2 lighting (cool-white + near-UV) with quinine actinometry.

Pull-Point Analysis

Validated stability-indicating HPLC / UPLC, dissolution, microbial limits and content tests at every pull.

Trending & Reporting

Pull-by-pull data tables, plots, trend analysis and shelf-life recommendation per ICH Q1E.

Regulatory Framework

Standards This Work Maps Onto

Methods, documentation and acceptance criteria are designed to align with the standards below. This describes design intent — formal accreditations are listed on the About page.

ICH Q1A(R2) — Stability of New Drug Substances and Products
ICH Q1B — Photostability
ICH Q1E — Evaluation of Stability Data
WHO Climatic Zones I–IVb
EU GMP Annex 19 — Reference and Retention Samples
MHRA / EU expectations for variations and renewals
What You Receive

Typical Deliverables

Stability protocol (ICH-formatted) approved before study start

Per-pull CoA at every time point

Stability summary report at study end with shelf-life recommendation

Trending plots (assay, related substances, dissolution, microbial)

Investigation reports for OOS / OOT pulls

Annual stability commitment management for marketed products

Who It's For

Sectors We Support

Drug-product manufacturers
API manufacturers
Generic and innovator companies
Nutraceutical brands needing shelf-life evidence
CDMOs preparing tech-transfer packages
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