NABL Accredited · ICH Q1A-Q1F Compliant

Pharmaceutical Stability Testing Laboratory India | ICH Compliant | NABL Accredited

Accelerated stability testing, long-term stability studies, and photostability testing per ICH guidelines from an NABL-accredited laboratory.

Accelerated stability testing is the cornerstone of pharmaceutical shelf-life determination — providing regulators and manufacturers with predictive degradation data in a compressed timeframe that supports initial product registration and market authorisation. Auriga Research operates an NABL-accredited stability testing laboratory with IQ/OQ/PQ-qualified environmental chambers maintained under ICH Q1A(R2) conditions, delivering stability data that CDSCO, US FDA, EMA, and WHO assessors accept for regulatory submissions across all dosage forms and climatic zones.

Our stability testing programme covers the complete 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) or 30 C/65% RH (Zone IVb for India and tropical markets) generate the definitive real-time data that underpins final shelf-life claims. Intermediate studies at 30 C/65% RH bridge the gap when accelerated data shows significant change. Photostability testing per ICH Q1B evaluates the sensitivity of drug substances and products to light exposure under controlled illumination conditions.

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, degradation products by HPLC/UHPLC), and microbiological testing are performed at each scheduled interval. Our LIMS 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.

Stability Testing Capabilities per ICH Q1A-Q1F

  • Accelerated stability testing: 40 C/75% RH — 6-month programme with monthly time points
  • Long-term stability: 25 C/60% RH or 30 C/65% RH — up to 36 months
  • Intermediate stability: 30 C/65% RH — 12-month programme
  • Refrigerated storage stability: 5 C plus or minus 3 C
  • Frozen storage stability: minus 20 C plus or minus 5 C
  • Photostability testing per ICH Q1B — Option 1 and Option 2 light exposure
  • Bracketing and matrixing study designs per ICH Q1D
  • Statistical shelf-life estimation and trend analysis per ICH Q1E
  • Physical, chemical, and microbiological stability-indicating testing
  • In-use stability and reconstituted product stability studies

Turnaround Time

Accelerated Study (6-month): 7-8 months including final report
Long-term Study (36-month): Interim reports at each time point
Per-Time-Point Analysis: 7-10 business days
Photostability Study: 4-6 weeks

Who Needs Stability Testing

  • ✓ Pharmaceutical manufacturers seeking CDSCO marketing authorisation with ICH-compliant stability data
  • ✓ Generic drug companies preparing ANDA/NDA filings for US FDA or EMA submissions
  • ✓ API manufacturers establishing retest periods and storage recommendations
  • ✓ Contract manufacturers requiring post-approval stability (PAS) monitoring
  • ✓ Companies performing SUPAC bridging studies after manufacturing site, formulation, or packaging changes

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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 the product shelf life in a shorter timeframe. Long-term stability testing stores products at 25 C/60% RH (or 30 C/65% RH for Zone IVb climates like India) for up to 36 months and provides the actual 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.
What are the ICH stability testing guidelines that your laboratory follows?
Auriga Research conducts stability studies compliant with the full suite of ICH stability guidelines: 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, ICH Q1E for evaluation of stability data and shelf-life estimation, and ICH Q1F (withdrawn but referenced) for climatic zone considerations. Our protocols are designed to satisfy CDSCO, US FDA, EMA, and WHO regulatory requirements simultaneously.
What storage conditions do you maintain for pharmaceutical stability studies?
Our stability chambers maintain ICH Q1A(R2) and WHO climate Zone IVb storage conditions: 25 C/60% RH (long-term), 30 C/65% RH (intermediate), 40 C/75% RH (accelerated), 5 C plus or minus 3 C (refrigerated), and minus 20 C plus or minus 5 C (frozen). All chambers are IQ/OQ/PQ-qualified, continuously monitored with calibrated temperature and humidity data loggers, and mapped per WHO Technical Report Series 961 requirements. Alarm systems with 24/7 monitoring ensure any excursion is detected and documented immediately.
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 12-36 months depending on the 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 7-8 months (including report preparation). We provide interim time-point reports as data becomes available.
Can you perform photostability testing per ICH Q1B?
Yes. Our photostability testing chamber delivers 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 Stability Testing for Your Product?

ICH Q1A-Q1F compliant accelerated stability testing from an NABL-accredited laboratory. Regulatory-ready reports for CDSCO and international submissions.

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