NABL CDSCO USFDA Inspected — Manesar & Bangalore ICH Q1B · Option 1 + Option 2

Photostability Testing Services | ICH Q1B | NABL Accredited | Auriga Research

NABL-accredited ICH Q1B photostability cabinets at Delhi, Manesar and Bangalore — Option 1 (combined UV + visible) and Option 2 (xenon arc D65/ID65) exposure for pharmaceutical drug substances, finished products, packaging and cosmetic / suncare formulations.

Photostability Cabinets at 3 Labs Across India

ICH Q1B photostability cabinets operate at Delhi (Arbro Analytical Division HQ), Manesar (USFDA Inspected, IMT Plot 136 Sector 5) and Bangalore (USFDA Inspected, WHO Prequalified). Each site runs Option 1 (combined UV + visible) and Option 2 (xenon arc D65/ID65) exposure with calibrated dosimetry, dark controls and 24/7 alarm-monitored chambers — three-lab capacity for parallel runs during peak filing windows.

Photostability testing assesses whether a pharmaceutical active ingredient or finished formulation degrades when exposed to controlled light conditions. It is a regulatory requirement for many drug products per ICH Q1B and an important step to determine appropriate labelling, packaging and storage conditions. Auriga Research delivers NABL-accredited photostability across three labs — Delhi, Manesar and Bangalore — with both ICH Q1B Option 1 and Option 2 exposure configurations available at every site.

Our laboratories expose samples to ICH Q1B defined light sources with dosimetry monitoring, while maintaining dark controls for direct comparison. Analytical results are reported alongside visual observations, pharmaceutical assay data and degradation profile analysis against ICH Q3A(R2)/Q3B(R2) impurity thresholds. Photostability data integrates seamlessly into a formal ICH stability package — accelerated (Q1A R2 40/75), intermediate (30/65), long-term Zone II (25/60) and Zone IVb (30/75 per WHO TRS 953 Annex 2) — with a single bar-coded YLIMS submission file.

Photostability testing is also available for cosmetic and personal-care products under ISO/TR 18811:2018 (Cosmetics — Guidelines on the stability testing of cosmetic products) and the EU Cosmetics Stability Testing Guidelines (Colipa / Cosmetics Europe). Cosmetic photostability protocols use the same validated chambers and dosimetry controls, with exposure conditions and acceptance criteria adapted to claims substantiation, colour stability and consumer-use storage rather than ICH thresholds — particularly relevant for sunscreens, serums, leave-on skincare and packaging photoprotection claims.

Photostability Testing Services

Each service mapped to its ICH Q1B option or ISO/EU cosmetic guideline for quick submission scoping.

ICH Q1B Opt 1

Option 1 Exposure — UV + Visible Combined

ICH Q1B Option 1 exposure — single combined UV and visible light source delivering minimum 1.2 million lux hours visible + 200 Wh/m² near-UV with calibrated dosimetry and dark controls.

ICH Q1B Opt 2

Option 2 Exposure — Xenon Arc D65 / ID65

ICH Q1B Option 2 exposure — xenon arc lamp simulating D65 (outdoor daylight) and ID65 (indoor indirect daylight) spectra with cool-white plus near-UV dose accumulation and dosimetric confirmation.

Forced

Forced Photodegradation Studies

Forced photodegradation studies for API and finished product — supra-ICH light dose to generate degradation products, develop stability-indicating methods and support impurity profiling per ICH Q3A(R2)/Q3B(R2).

ICH Pkg

Photostability in ICH Stability Package

Photostability delivered as part of a formal ICH stability package alongside accelerated (Q1A R2 40/75), intermediate, long-term Zone II and Zone IVb (WHO TRS 953 Annex 2) studies — single SPOC and single submission file.

Cosmetic

Cosmetics & Suncare Photostability

Photostability for cosmetics and suncare products per ISO/TR 18811:2018 and the EU Cosmetics Stability Testing Guidelines — claims substantiation, colour stability and packaging photoprotection for sunscreens, serums and leave-on skincare.

Packaging

Packaging Photoprotection Assessment

Packaging photoprotection assessment — amber glass, blister overwrap, secondary carton and label-printed barriers tested for transmittance and photoprotective performance of the assembled pack.

How It Works — 4 Steps to Your NABL Photostability Report

1

Get a Quote

Share product type, development phase and whether you need standalone photostability or integrated into an ICH stability package. Your SPOC confirms ICH Q1B option (Option 1 vs Option 2), lab assignment 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 photostability cabinets at Delhi, Manesar or Bangalore. 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 via YLIMS.

Typical Turnaround Time

Service Standard TAT
ICH Q1B Photostability Study (Option 1 or Option 2) 4-6 weeks
Method Setup & Sampling Plan 1-2 weeks
Forced Photodegradation Study 3-5 weeks
Cosmetic / Suncare Photostability (ISO/TR 18811) 4-6 weeks
Report Delivery (after analysis complete) 1 week

Expedited options available on request. Photostability runs in parallel with the rest of an ICH Q1A(R2) stability package — no additional calendar time on the submission critical path when commissioned together.

Who Needs Photostability Testing

  • ✓ Pharma manufacturers required to include photostability data in CDSCO or USFDA dossier per ICH Q1B
  • ✓ Generic developers generating photostability data for ANDA filings and shelf-life justification
  • ✓ CDMO clients requiring photostability as part of formulation development and tech transfer
  • ✓ Cosmetics and suncare brands validating photoprotection packaging claims per ISO/TR 18811
  • ✓ API manufacturers generating photodegradation profiles to support DMF and stability-indicating method development
  • ✓ Innovator pharma submitting CTD Module 3.2.S.7 (Stability) packages requiring Q1B evidence
  • ✓ Sterile and parenteral manufacturers documenting photolability for light-sensitive injectable APIs
  • ✓ Excipient and primary-pack suppliers documenting photoprotective container performance for incoming-material release

Why Auriga for Photostability Testing

Photostability Cabinets at 3 Labs

Dedicated ICH Q1B photostability cabinets at Delhi, Manesar and Bangalore — three-lab capacity for parallel runs without queueing during peak filing windows.

USFDA Inspected — Data Accepted Globally

Manesar and Bangalore are USFDA Inspected facilities — photostability data generated at these sites is accepted in USFDA dossiers, ANDA filings and EMA submissions without re-testing.

ICH Q1B Option 1 AND Option 2 Available

Both Option 1 (combined source) and Option 2 (xenon arc D65/ID65) configurations available at every photostability site — choose the option that matches your sponsor’s preferred submission strategy.

Stability-Indicating Methods In-House

Method development and validation per ICH Q2(R2) and Q14 happens in the same lab — no handoff between photostability execution and the analytical lab that runs the assay/related-substances panel.

Cosmetic + Pharma Photostability Under One Roof

ICH Q1B for drug products and ISO/TR 18811:2018 for cosmetics on the same cabinets and dosimetry — D2C suncare brands and pharma sponsors served by one SPOC.

Integrates with Full ICH Stability Package

Photostability is run in parallel with accelerated (40/75), intermediate (30/65), long-term (25/60) and Zone IVb (30/75 WHO TRS 953 Annex 2) studies — single bar-coded YLIMS submission file.

5+

NABL Labs

5 Cities

Delhi · Manesar · Bahadurgarh · Baddi · Bangalore

12,000+

Clients Served

1985

Arbro Group Established

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Frequently Asked Questions — Photostability Testing

What is photostability testing?
Photostability testing is the evaluation of a pharmaceutical drug substance or product under controlled light exposure to assess its sensitivity to UV and visible radiation. It is performed per ICH Q1B guidelines to determine whether light causes degradation, colour change or loss of potency. The technique is also used for cosmetic and personal-care products under ISO/TR 18811:2018 and the EU Cosmetics Stability Testing Guidelines.
Where are Auriga photostability cabinets located?
Auriga Research operates ICH Q1B photostability cabinets at three labs across India — Delhi (Arbro Analytical Division HQ), Manesar (USFDA Inspected, IMT Plot 136 Sector 5) and Bangalore (USFDA Inspected, WHO Prequalified). All three labs run Option 1 (combined UV and visible) and Option 2 (xenon-arc simulating D65 and ID65) exposure conditions with calibrated dosimetry, dark controls and 24/7 alarm-monitored chambers. Three-lab capacity supports parallel runs for sponsors with stacked photostability workloads.
Which products need ICH Q1B photostability studies?
Pharmaceutical products that are likely to be exposed to light during storage, handling or administration need photostability studies. This includes solid oral dosage forms, liquids, injectables, aerosols, creams, ointments and packaging components that may transmit or react to light. ICH Q1B remains the current active guideline for pharmaceutical photostability; ICH is developing a consolidated ICH Q1 guideline that will incorporate photostability guidance aligned with Q1B principles. Auriga's protocols are designed to meet both current ICH Q1B and the anticipated consolidated ICH Q1 requirements.
What does the photostability test report include?
The report includes light exposure conditions (Option 1 or Option 2 selection per ICH Q1B), dosimetry results (minimum 1.2 million lux hours visible light and 200 watt-hours per square metre near-UV), appearance observations, assay and degradation product analysis against ICH Q3A/Q3B thresholds, dark-control comparison, photostability compliance per ICH Q1B and recommendations for packaging or labelling if photolability is observed.
How fast can photostability testing be completed?
Photostability testing is typically completed in 4-6 weeks depending on the number of dosage forms, packaging conditions and analytical method requirements. Rush options can be arranged for product development timelines or regulatory submissions. When integrated as the photostability arm of a formal ICH stability package, the work runs in parallel with the accelerated and long-term programmes — no additional calendar time on the critical path.

Need ICH Q1B Photostability Testing for Your Product?

NABL-accredited photostability cabinets at Delhi, Manesar and Bangalore. ICH Q1B Option 1 and Option 2 exposure with calibrated dosimetry, dark controls and full stability-indicating assay support — reports formatted for CDSCO, USFDA and EMA submission.

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