Herbal & AYUSH Stability Testing
AYUSH and herbal product manufacturers declare shelf life on the label, in the AYUSH licence dossier, and on export packs. Without stability data backing the claim, the AYUSH licence application is incomplete, EU and Gulf import dossiers are rejected, and reformulation work cannot progress. Auriga Research provides NABL-accredited stability testing scoped specifically for herbal, Ayurvedic, Unani, Siddha, and Homeopathy products per the AYUSH GMP framework (Schedule T) with Zone IV (30 °C / 75 % RH) as the India and tropical-market default long-term condition.
Our programme covers accelerated stability (40 °C / 75 % RH, 3 to 6 months — predicting 2-year shelf life), real-time long-term Zone IV (30 °C / 75 % RH, 12 to 24 months — confirming the declared shelf-life claim), photostability per ICH Q1B for light-sensitive formulations, marker compound assay tracking per the relevant API / UPI / SPI monograph, microbial stability per ISO 17516 and pharmacopoeial methods, and container-closure compatibility. Bhasma and rasashastra preparations are tracked against per-preparation API criteria rather than standard herbal-extract criteria.
Stability chambers are operated at Delhi and Manesar, with the broader Auriga chamber matrix covering accelerated, long-term, intermediate Zone IV, elevated stress, refrigerated, frozen, ultra-low, and freeze-thaw conditions. Backed by the Arbro Group's unbroken NABL ISO/IEC 17025:2017 accreditation since 2003 and Delhi HQ's status as India's first herbal lab licensed by the Directorate of ISM&H, reports are accepted by the Ministry of AYUSH, CDSCO, state AYUSH licensing authorities, and EU / US / Gulf / ASEAN export regulators.
Six AYUSH Stability Study Types
Each card shows the study type, the regulatory anchor, the chamber condition, and the dossier purpose. Zone IV (30 °C / 75 % RH) is the India and tropical-market default long-term condition.
Accelerated Stability (40 °C / 75 % RH)
Accelerated stress condition per AYUSH GMP and ICH framework, run for 3 to 6 months. Predicts a 2-year shelf life. Pull points at 0, 1, 2, 3, and 6 months for the full parameter panel.
Long-Term Stability — Zone IV (30 °C / 75 % RH)
India and tropical-market default long-term condition for 12 to 24 months. Directly confirms the declared shelf-life claim on the AYUSH licence dossier and on export labels.
Photostability (ICH Q1B)
Defined light-exposure protocol for AYUSH formulations packaged in transparent containers or containing light-sensitive constituents (curcuminoids, anthraquinones, photo-active markers).
Marker Compound Assay Over Time
HPLC and HPTLC-based marker compound quantification at each pull point per the API / UPI / SPI monograph. Tracks potency decay across shelf life — central to AYUSH stability evidence.
Microbial Stability per Pharmacopoeia
TAMC, TYMC, and absence of specified pathogens (E. coli, Salmonella, S. aureus) tracked across the stability window. Confirms the preservation system holds across declared shelf life.
Container-Closure Compatibility
Formula-container interaction tracked across the storage window. Critical for amber-glass arishta bottles, plastic churna sachets, aluminium-tube taila, and traditional kupi-bandh rasashastra packaging.
AYUSH GMP Schedule T: Schedule T of the Drugs and Cosmetics Rules sets out the AYUSH GMP framework. Stability data supports the declared shelf-life claim on the AYUSH licence dossier. The India default long-term condition is Zone IV (30 °C / 75 % RH); the standard accelerated condition is 40 °C / 75 % RH. The ICH framework (Q1A, Q1B) is used as a design template where AYUSH-specific guidance is silent.
How It Works
Get a Quote
Share your product (raw herb, extract, churna, vati, kashaya, taila, arishta, bhasma, finished AYUSH formulation), the declared shelf life, the AYUSH framework (API / UPI / SPI / Homeopathy), and the target market (Ministry of AYUSH, CDSCO, EU / US / Gulf). Your dedicated SPOC confirms the stability protocol, chamber conditions, pull-point schedule, parameter panel, and sample quantity before you dispatch.
Send Your Samples
Dispatch product samples in their final commercial packaging with a completed Test Request Form to the Delhi HQ (Arbro Analytical Division) or Manesar lab. Each sample is bar coded and registered in YLIMS, Auriga's in-house Laboratory Information Management System, upon receipt. Time-point zero (T0) baseline testing begins within 24 hours.
Stability Pull and QA Review
Samples are placed in the appropriate chamber. At each pre-defined pull point (T0, 1, 2, 3, 6 months for accelerated; quarterly for Zone IV long-term), aliquots are pulled and tested for the agreed physical, chemical (marker assay), and microbiological parameters per the AYUSH / API monograph. All results pass through formal internal QA review and sign-off before each interim report is generated.
Receive Your NABL Report
Interim reports are delivered at each pull point; the final report is delivered after the last pull. Reports cite the AYUSH GMP Schedule T framework, the API / UPI / SPI monograph reference, and the shelf-life verdict. Accepted by Ministry of AYUSH, CDSCO, state AYUSH licensing authorities, and EU / US / Gulf / ASEAN export regulators. Track sample status and interim time-point results in real time through YLIMS.
Study Timelines
| Study Type | Standard Duration | Notes |
|---|---|---|
| Accelerated stability per AYUSH GMP (40 °C / 75 % RH) | 3 to 6 months | Interim reports at 1, 2, 3, 6 months |
| Long-term Zone IV stability (30 °C / 75 % RH) | 12 to 24 months | Quarterly interim reports |
| Photostability per ICH Q1B | 4 to 6 weeks | For light-sensitive formulations or transparent packaging |
| Preliminary screening study | 4 to 8 weeks | Formulation triage before full programme |
| Freeze-thaw / transport simulation | 4 to 6 weeks | For taila, ghrita, and refrigerated arishta |
| Marker compound assay (single pull point) | 5 to 7 business days | On request between pull points |
| Microbial stability (single pull point) | 5 to 7 business days | On request between pull points |
Who Needs AYUSH Stability Testing
- AYUSH-licensed manufacturers preparing Ministry of AYUSH licence applications or renewals that need stability data backing the declared shelf life.
- Ayurvedic, Unani, Siddha, and Homeopathy formulators launching new products or new packaging where fresh stability evidence is required.
- Bhasma and rasashastra manufacturers needing per-preparation API monograph stability evidence including physical integrity and heavy metal assay over time.
- Herbal supplement and nutraceutical brands with botanical actives needing shelf-life substantiation before retail and marketplace launch.
- Exporters supplying EU, US, Gulf, ASEAN, and African markets requiring Zone IV stability data and WHO-aligned herbal-medicine evidence.
- Brands reformulating preservation systems, fragrance, or active markers and needing fresh stability data on the new formula.
- AYUSH GMP auditees facing inspection where shelf-life evidence is a check point under Schedule T compliance review.
- Brands contesting a CDSCO, state AYUSH, or import-side shelf-life finding — full re-test on NABL chain of custody.
Why Auriga for AYUSH Stability
Stability Chambers at Delhi and Manesar
Full chamber matrix: accelerated 40 °C / 75 % RH, long-term Zone IV 30 °C / 75 % RH, intermediate, elevated stress 50 / 57 / 60 °C, refrigerated 2 to 8 °C, frozen -20 °C, ultra-low -40 °C / -80 °C, plus freeze-thaw cycling.
AYUSH GMP Schedule T Aligned
Studies designed against the AYUSH GMP framework (Schedule T of the Drugs and Cosmetics Rules) with marker compound assay per the API / UPI / SPI monograph and microbial limits per ISO 17516.
First ISM&H-Licensed Herbal Lab
Delhi HQ is India's first herbal testing lab licensed by the Directorate of ISM&H, AYUSH approved since 2004 (DTL-01 A&U), and holder of the Unani licence. The audit trail Ministry of AYUSH and export regulators look for.
Marker Compound Assay Integrated
HPTLC and HPLC marker compound quantification integrated with stability pulls. Potency decay across shelf life is the central AYUSH stability evidence — not just physical observation.
Bhasma API-Specific Tracking
Bhasma and rasashastra preparations tracked against per-preparation API criteria — physical integrity, particle-size where applicable, marker element assay, and bhasma API-specific heavy metal limits. Not standard herbal-extract criteria.
Reports Accepted by AYUSH, CDSCO, EU, Gulf
NABL ISO/IEC 17025:2017 reports accepted by the Ministry of AYUSH, CDSCO, state AYUSH licensing authorities, and EU / US / Gulf / ASEAN export regulators. Arbro Group analytical heritage since 2003.