Nutraceutical Stability Testing | ICH Q1A | NABL Accredited
Without analytically supported shelf-life data, a nutraceutical brand has no defence against FSSAI label-claim challenges, marketplace product complaints, or distributor returns near end of life. Backed by the Arbro Group's unbroken NABL accreditation since 2003, Auriga Research runs full accelerated and real-time stability studies for health supplements, dietary supplements, probiotics, and functional foods under ICH Q1A conditions.
Stability data is mandatory under the FSS (Health Supplements, Nutraceuticals, Food for Special Dietary Use, FSMP, Functional Food and Novel Food) Regulations 2016 Form B nutraceutical licence dossier. Our walk-in stability chambers operate at ICH Q1A(R2) Climate Zone IVa conditions for India — accelerated (40 °C / 75% RH), intermediate (30 °C / 65% RH), and long-term real-time (30 °C / 75% RH) — plus refrigerated 5 °C ± 3 °C chambers for fish oil, krill oil, and probiotics, and ICH Q1B photostability for vitamin and fat-soluble formulations.
Every chamber is on continuous temperature and humidity monitoring with deviation alarms and a full audit trail in YLIMS — the same monitoring evidence FSSAI assessors and international auditors look for.
Stability Conditions & Parameters
Each parameter is mapped to its ICH condition or method so QA teams can match scope to FSSAI / Form B requirements at a glance.
Accelerated (40 °C / 75% RH)
Accelerated stability per ICH Q1A(R2) — 28-day screening or 6-month full study. Used for early shelf-life prediction and supplier qualification.
Intermediate (30 °C / 65% RH)
30 °C / 65% RH intermediate condition — triggered where significant change occurs in accelerated study or as required by jurisdiction.
Long-term (30 °C / 75% RH)
Long-term Zone IVa real-time condition for India — 12 to 36 months matching the claimed shelf life on the label.
Refrigerated Stability
5 °C ± 3 °C refrigerated condition for fish oil, krill oil, refrigerated probiotics, and live-microorganism supplements.
Photostability
ICH Q1B photostability test — confirmatory exposure to ICH Option 2 light source. Critical for vitamin C, B2, and fat-soluble vitamin photodegradation profiling.
Vitamin Assay Trending
HPLC assay of declared vitamins at each stability time point — supports the 80% claim floor at end of shelf life per FSSAI 2016.
Mineral Assay Trending
ICP-OES assay of declared minerals at each time point — minerals are typically stable but premix qualification still needs verification.
Omega Fatty Acid Trending
GC-FID for EPA / DHA / ALA at each time point — fish oil and omega supplements are particularly oxidation-prone and need active monitoring.
Probiotic Viability Trending
Strain-specific viable cell counts at each time point — typical probiotic stability shows 1–2 log loss across 24 months in optimised packaging.
Moisture Content
Karl Fischer moisture for capsules, tablets, powders, and sachets — moisture pickup during stability is the leading cause of probiotic and vitamin loss.
Microbial Limits Trending
TPC, yeast and mould, pathogen testing at each time point — confirms preservative system efficacy across the full shelf life.
Physical Attributes
Appearance, colour, hardness, friability, disintegration, dissolution, pH, viscosity — supports tablet, capsule, sachet, and liquid SKU integrity.
How It Works
Get a Quote
Share your product type and the parameters you need tested. Your dedicated SPOC will confirm the testing scope, the applicable method, and the exact sample quantity required for your specific panel before you dispatch anything.
Send Your Sample
Dispatch your sample with a completed Test Request Form to the nearest Auriga lab. Each sample is individually bar coded and registered in YLIMS, Auriga's in-house Laboratory Information Management System, upon receipt. Testing begins within 24 hours of sample registration.
Testing and QA Review
Your sample is tested against the confirmed validated method by Auriga's scientific team. Every result passes through a formal internal QA review and sign-off before the report is generated.
Receive Your NABL Report
Your NABL-accredited test report is delivered digitally within the committed turnaround time. Reports carry Auriga's NABL accreditation under ISO/IEC 17025:2017 and are accepted by FSSAI under the Health Supplements Regulations 2016, BIS, and international buyers. You can track your sample status in real time through YLIMS at any point in the process.
Turnaround Time
| Study Type | Standard TAT | Express |
|---|---|---|
| Screening accelerated (28 days) | 4–6 weeks total | On request |
| Full accelerated study (6 months at 40 °C / 75% RH) | 7 months elapsed | — |
| Intermediate (30 °C / 65% RH) — triggered | 6–12 months | — |
| Long-term real-time (12–36 months at 30 °C / 75% RH) | 12–36 months elapsed | — |
| Refrigerated (5 °C ± 3 °C) for probiotics / fish oil | 6–24 months elapsed | — |
| Photostability (ICH Q1B confirmatory) | 4–6 weeks | Available |
Who Needs This Testing
- Nutraceutical manufacturers preparing FSSAI Form B Nutraceutical Licence dossiers — stability data is a mandatory component of the submission.
- D2C supplement and probiotic brands needing analytically supported "Best Before" or "Use By" dates for product launch and marketplace listing.
- Brands extending shelf-life claims (12 to 24 months, 24 to 36 months) and needing real-time data to support the extension.
- Manufacturers running supplier qualification on a new active-ingredient source, premix, or excipient base — accelerated stability screens predict the impact.
- Probiotic and live-microorganism supplement brands needing CFU stability through the full shelf life to defend the label CFU claim.
- Brands launching in new packaging formats (sachet vs blister, glass vs HDPE bottle, primary vs secondary moisture barrier) needing packaging-specific stability data.
- Brands exporting to humid climate markets and needing Zone IVa data to support shelf-life claims in destination jurisdictions.
Why Auriga for Stability Testing
Unbroken NABL accreditation since 2003
Arbro Group has held NABL ISO/IEC 17025 accreditation continuously since 2003 covering stability assay and microbial trending across the FSSAI 2016 scope.
Walk-in ICH Q1A chambers with continuous monitoring
Multiple walk-in chambers at Zone IVa accelerated, intermediate, long-term, and refrigerated set points — full temperature and humidity audit trail with deviation alarms in YLIMS.
Full assay scope under one roof
Vitamins by HPLC, minerals by ICP-OES, omegas by GC-FID, probiotic CFU, microbial limits, moisture, and physical attributes all run on the same sample at each time point.
ICH Q1B photostability in-house
Validated ICH Option 2 photostability cabinet for vitamins, carotenoids, and fat-soluble actives — no partner-lab dependency for the photostability arm of the dossier.
FSSAI Form B dossier-ready output
Stability reports formatted for direct paste into the FSSAI Form B nutraceutical licence dossier and Form C licence applications — minimises submission revisions.
Five regional labs
Delhi, Gurugram, Bangalore, Baddi, and Bahadurgarh — closer to your factory or warehouse means easier ongoing sample dispatch through the multi-year study window.