NABL CDSCO USFDA Inspected — Manesar & Bangalore ICH Q1A(R2) · Q1B · Q1C · Q1D · Q1E

Pharmaceutical Stability Testing | ICH Q1A Q1B Q1C Q1D | NABL Accredited | Auriga Research

Accelerated, long-term, intermediate, photostability and Zone IVb stability studies from IQ/OQ/PQ-qualified chambers at Delhi, Baddi, Manesar and Bangalore.

Stability Chamber Network — 4 Labs Across India

IQ/OQ/PQ-qualified stability chambers operate at Delhi (Arbro Analytical Division HQ), Baddi (Himachal Pradesh — pharma manufacturing cluster), Manesar (USFDA Inspected) and Bangalore (USFDA Inspected, WHO Prequalified). Photostability per ICH Q1B operates at Delhi, Manesar and Bangalore. All chambers are continuously monitored with calibrated data loggers, mapped per WHO TRS 961 and tied to 24/7 alarm response.

Pharmaceutical stability testing is the cornerstone of shelf-life determination — providing regulators and manufacturers with the predictive degradation data that supports product registration and commercial release. Auriga Research operates an NABL-accredited stability testing programme with IQ/OQ/PQ-qualified environmental chambers maintained under ICH Q1A(R2) conditions across four labs, delivering stability data that CDSCO, USFDA, EMA and WHO assessors accept for regulatory submissions across all dosage forms and climatic zones.

Our programme covers the complete current ICH Q1 guideline suite. Accelerated studies at 40 C / 75% RH provide early degradation signals and support provisional shelf-life assignments. Long-term studies at 25 C / 60% RH (Zone II) and 30 C / 75% RH (Zone IVb per WHO TRS 953 Annex 2) generate the definitive real-time data that underpins final shelf-life claims for India and tropical markets. Intermediate studies at 30 C / 65% RH bridge the gap when accelerated data shows significant change. Photostability per ICH Q1B evaluates light sensitivity under controlled illumination at Delhi, Manesar and Bangalore.

Each stability study is designed with a protocol specifying time points, test parameters, acceptance criteria and statistical evaluation methods per ICH Q1E. Physical testing (appearance, colour, pH, dissolution, hardness), chemical testing (assay, related substances and degradation products by HPLC and UPLC) and microbiological testing are performed at every scheduled interval. YLIMS tracks every sample, time point and result with full audit trail, and formal stability reports include trend charts, statistical shelf-life calculations and all raw analytical data formatted for direct regulatory submission.

Stability Testing Services

Each service mapped to the current ICH or WHO guideline so submission packages can be scoped at a glance.

Real-Time

Real-Time Stability

Long-term storage at 25 C / 60% RH (Zone II) per ICH Q1A(R2). Up to 36-month programmes with interim pulls.

Accelerated

Accelerated Stability

40 C / 75% RH 6-month programme with monthly time points per ICH Q1A(R2). Supports initial registration filings.

Intermediate

Intermediate Stability

30 C / 65% RH 12-month programme per ICH Q1A(R2) when accelerated study shows significant change.

ICH Q1B

Photostability Testing

Photostability per ICH Q1B Option 2 at Delhi, Manesar and Bangalore — 1.2 million lux hours plus 200 Wh/m² near-UV.

Freeze-Thaw

Freeze-Thaw Cycling

Freeze-thaw cycling studies for biologics, parenterals and reconstituted products to evaluate physical stability under transport excursions.

Zone IVb

Zone IVb Stability

Long-term stability at 30 C / 75% RH per WHO TRS 953 Annex 2 — Zone IVb conditions for India and tropical markets.

How It Works — 4 Steps to Your NABL Stability Report

1

Get a Quote

Share product name, dosage form, proposed shelf life and target markets. Your SPOC confirms applicable ICH or WHO conditions, number of time points and TAT.

2

Collect and Send Your Sample

Prepare per SPOC instructions at quote stage. Each sample is bar-coded and registered in YLIMS on receipt with full chain-of-custody.

3

Testing and QA Review

Tested under NABL-accredited conditions in IQ/OQ/PQ-qualified chambers. Per-time-point results pass through formal QA review before release.

4

Receive Your NABL Report

NABL report delivered digitally within committed TAT, formatted for CDSCO, USFDA and regulatory submission. Track every time point via YLIMS.

Project Timelines

Study Type Duration First Time Point Report
Accelerated Stability (Q1A R2 — 40/75) 6 months 7-8 months including final report
Intermediate Stability (Q1A R2 — 30/65) 12 months Interim pulls at 0, 3, 6, 9, 12 months
Long-Term / Zone II (25/60) 12-36 months Interim pulls at every scheduled point
Zone IVb (30/75 — WHO TRS 953 Annex 2) 12-36 months Interim pulls at every scheduled point
Photostability (ICH Q1B Option 2) 4-6 weeks Single final report
Per-Time-Point Analysis 7-10 working days Per-pull interim report

Note on per-time-point TAT: Standalone HPLC assay / related substances on the parent pharma TAT table is quoted at 5-7 working days. Stability-specific per-time-point analysis takes 7-10 days because each pull involves controlled retrieval from qualified chambers with chamber-condition reconciliation, the full stability-indicating method battery (assay + related substances + degradation products + physical parameters, often with microbiology), and stability-package documentation (per-time-point report, trend update, deviation log if any, and audit trail linkage to the protocol). Express stability time-points can be arranged on request.

Who Needs Pharmaceutical Stability Testing

  • ✓ Pharma manufacturers generating stability data for CDSCO or USFDA dossier submissions
  • ✓ Generic companies conducting accelerated stability for shelf-life prediction in ANDA filings
  • ✓ CDMO clients requiring stability studies as part of formulation development and tech transfer
  • ✓ Exporters requiring Zone IVb tropical stability data for India, Africa, Latin America and Southeast Asia
  • ✓ API manufacturers establishing retest periods and storage recommendations for DMF submissions
  • ✓ Companies performing SUPAC bridging studies after manufacturing site, formulation or packaging changes
  • ✓ Biologics and parenteral manufacturers requiring freeze-thaw and refrigerated-chain stability
  • ✓ Contract manufacturers monitoring post-approval stability (PAS) for commercial product lines

Why Auriga for Stability Testing

Stability Chambers at 4 Labs

IQ/OQ/PQ-qualified chambers at Delhi, Baddi, Manesar and Bangalore covering all ICH and WHO climatic-zone conditions in one network.

USFDA Inspected — Data Accepted Globally

Manesar and Bangalore are USFDA Inspected facilities — stability data is accepted in USFDA dossiers, ANDA filings and EMA submissions.

Photostability at 3 Labs

ICH Q1B Option 2 photostability cabinets operate at Delhi, Manesar and Bangalore — capacity for parallel photostability runs without queueing.

Current ICH Guideline Suite

ICH Q1A(R2), Q1B, Q1C, Q1D and Q1E — Q1F withdrawal acknowledged with WHO TRS 953 Annex 2 substitution for Zone IVb.

Full ICH and WHO Climate Matrix

Zone II (25/60), Zone IVa (30/65), Zone IVb (30/75), accelerated (40/75), refrigerated (5±3) and frozen (-20±5) — every condition under one accreditation.

Stability-Indicating Methods In-House

Method development and validation per ICH Q2(R2) and Q14 happens in the same lab — no protocol-to-method handoff between vendors.

5+

NABL Labs

5 Cities

Delhi · Manesar · Bahadurgarh · Baddi · Bangalore

12,000+

Clients Served

1985

Arbro Group Established

Regulatory References Cited on Auriga Stability Reports

  • · ICH Q1A(R2) — Stability Testing of New Drug Substances and Products
  • · ICH Q1B — Photostability Testing of New Drug Substances and Products
  • · ICH Q1C — Stability Testing for New Dosage Forms
  • · ICH Q1D — Bracketing and Matrixing Designs for Stability Testing
  • · ICH Q1E — Evaluation of Stability Data and Shelf-Life Estimation
  • · WHO TRS 953 Annex 2 — Stability testing of APIs and FPPs (Zone IVb for India and tropical markets)
  • · WHO TRS 961 — Chamber mapping and qualification
  • · CDSCO stability requirements for marketing authorisation
  • Note: ICH Q1F was withdrawn in 2006. Climatic zone considerations (including Zone IVb) are now covered under WHO TRS 953 Annex 2 and the climatic-zone Appendix of ICH Q1A(R2).

Related Testing Services

Method Development & Validation HPLC and UPLC Testing Finished Product Testing Cosmetic Stability Testing NABL Accredited Lab All Pharma Testing →

Frequently Asked Questions — Stability Testing

What is accelerated stability testing and how does it differ from long-term stability?
Accelerated stability testing subjects pharmaceutical products to elevated stress conditions — typically 40 C/75% RH for 6 months per ICH Q1A(R2) — to predict shelf life in a compressed timeframe. Long-term stability testing stores products at 25 C/60% RH (Zone II) or 30 C/65% RH (Zone IVb for India and tropical markets) for up to 36 months and provides the definitive real-time data that regulatory authorities use to assign shelf life. Accelerated data supports initial registration filings and identifies potential degradation pathways early in development.
Which ICH stability guidelines does Auriga Research follow?
Auriga Research conducts stability studies compliant with the active ICH stability guideline suite: ICH Q1A(R2) for stability testing of new drug substances and products, ICH Q1B for photostability testing, ICH Q1C for new dosage forms of registered products, ICH Q1D for bracketing and matrixing designs, and ICH Q1E for evaluation of stability data and shelf-life estimation. ICH Q1F was withdrawn in 2006 — climatic zone considerations (including Zone IVb conditions relevant for India and tropical markets) are now covered under WHO TRS 953 Annex 2 (Stability testing of active pharmaceutical ingredients and finished pharmaceutical products) and the climatic-zone Appendix of ICH Q1A(R2). Our protocols are designed to satisfy CDSCO, USFDA, EMA and WHO regulatory requirements simultaneously.
Where are Auriga stability chambers located?
Auriga Research operates IQ/OQ/PQ-qualified stability chambers at four labs across India — Delhi (Arbro Analytical Division HQ), Baddi (Himachal Pradesh — adjacent to the pharma manufacturing cluster), Manesar (USFDA Inspected) and Bangalore (USFDA Inspected, WHO Prequalified). All chambers are continuously monitored with calibrated temperature and humidity data loggers, mapped per WHO TRS 961 requirements and tied to 24/7 alarm monitoring so any excursion is detected and documented immediately. Photostability cabinets per ICH Q1B operate at Delhi, Manesar and Bangalore.
What storage conditions do you maintain for pharmaceutical stability studies?
Our stability chambers maintain the full ICH Q1A(R2) and WHO climate-zone storage condition matrix: 25 C/60% RH (Zone II long-term), 30 C/65% RH (Zone IVa long-term and intermediate), 30 C/75% RH (Zone IVb long-term for India and tropical markets per WHO TRS 953 Annex 2), 40 C/75% RH (accelerated), 5 C plus or minus 3 C (refrigerated) and minus 20 C plus or minus 5 C (frozen). Photostability per ICH Q1B Option 2 delivers a minimum 1.2 million lux hours of visible light and 200 watt-hours per square metre of near-UV radiation alongside light-monitoring dosimetry and dark controls.
How long does a pharmaceutical stability study take?
Accelerated stability studies run for 6 months with testing at 0, 1, 2, 3 and 6-month time points. Intermediate studies run for 12 months with testing at 0, 3, 6, 9 and 12 months. Long-term studies run for 12 to 36 months depending on regulatory requirements, with testing at 0, 3, 6, 9, 12, 18, 24 and 36-month intervals. Initial accelerated data for registration filing is typically available within 7 to 8 months (including report preparation). Interim time-point reports are issued as data becomes available so the regulatory clock does not wait for the final pull.
Can you perform photostability testing per ICH Q1B?
Yes. Photostability cabinets at Delhi, Manesar and Bangalore deliver Option 2 exposure conditions per ICH Q1B — a minimum of 1.2 million lux hours of visible light and 200 watt-hours per square metre of near-UV radiation. Samples are exposed alongside light-monitoring dosimetry controls and dark controls. Photostability data is integrated into the overall stability programme and reported with all analytical results, appearance changes and statistical analysis of any degradation observed.

Need ICH-Compliant Stability Data for Your Submission?

ICH Q1A(R2), Q1B, Q1C, Q1D and Q1E compliant stability testing from IQ/OQ/PQ-qualified chambers at Delhi, Baddi, Manesar and Bangalore. Reports formatted for CDSCO, USFDA and EMA submission.

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