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Every pharmaceutical, herbal, food, or cosmetic product needs a defined shelf life backed by science. At Prism Analytical Research, we conduct comprehensive stability studies as per ICH, WHO, and regulatory guidelines, helping manufacturers establish, verify, and extend product stability under various storage conditions.
Whether you’re in R&D, scale-up, or dossier submission stage, we provide reliable data to support your product claims and meet compliance standards.
We conduct real-time and accelerated testing in ICH-recommended climatic zones (Zone I–IV), analyzing key quality attributes like:
Assay
Degradation products
Dissolution
Appearance
pH
Moisture content
Microbial load
Testing under controlled UV and visible light exposure as per ICH Q1B to ensure product is not light-sensitive or reactive.
Evaluation of product behaviour under extreme conditions, like repeated freeze-thaw cycles, to simulate distribution challenges.
Testing of the packaging’s protective ability, interaction, and impact on product stability over time.
Useful for multi-dose or reconstituted products — checks stability after opening, dilution or handling.
Determination of shelf life for non-drug products such as swabs, syringes, and diagnostic kits.
All chambers are 21 CFR Part 11 compliant and monitored continuously with backup.
Your product’s future depends on how well it stands the test of time. We help you prove it — with precision and compliance.
The Department of Chemical Research Support is a central research resource facility of the Institute of Science.
