Long-term and accelerated stability studies for research and pharmaceutical peptides. Determine shelf life, optimal storage conditions, and degradation pathways per ICH Q1A guidelines.
Peptide stability testing monitors purity, identity, and potency over time under defined temperature and humidity conditions. Cert Biohealth Testing Labs offers ICH Q1A(R2)-compliant long-term (25°C/60% RH), intermediate (30°C/65% RH), and accelerated (40°C/75% RH) stability protocols with HPLC purity and MS identity checkpoints at T=0, 1, 3, 6, 9, and 12 months. Accelerated studies can provide preliminary shelf-life data in 3–6 months.
40°C/75% RH conditions to predict long-term stability in a compressed timeframe. Ideal for estimating shelf life before committing to a full 24-month study.
25°C/60% RH conditions monitored over 12–36 months for regulatory shelf-life establishment and expiry dating.
Cyclic freeze-thaw stress testing to evaluate stability of lyophilized peptides and aqueous formulations during shipping and storage.
ICH Q1B-compliant light stress testing to assess photodegradation of photosensitive peptides under UV and visible light exposure.
Compatibility studies evaluating peptide stability in different excipient systems, buffers, and reconstitution vehicles.
Stress testing under acid, base, oxidative, thermal, and photolytic conditions to identify degradation pathways and establish specificity of analytical methods.
| Study Type | Temperature | Humidity | Duration | Typical Use |
|---|---|---|---|---|
| Long-term | 25°C ± 2°C | 60% ± 5% RH | 12–36 months | Shelf-life establishment |
| Intermediate | 30°C ± 2°C | 65% ± 5% RH | 6–12 months | Zone II/III climates |
| Accelerated | 40°C ± 2°C | 75% ± 5% RH | 6 months | Predictive shelf life |
| Refrigerated | 5°C ± 3°C | Ambient | 12–24 months | Cold-chain peptides |
| Frozen | −20°C ± 5°C | N/A | Up to 36 months | Long-term frozen storage |
Accelerated studies (40°C/75% RH) take 6 months to complete and provide early shelf-life predictions. Full ICH Q1A(R2) long-term studies at 25°C run for 12–36 months. Studies begin as soon as we receive your T=0 samples and are maintained continuously on your behalf.
Standard timepoints include: RP-HPLC purity (primary stability-indicating method), ESI-MS identity confirmation, visual inspection (appearance, colour, particulates), and pH if in solution. Additional tests such as endotoxin, sub-visible particle count, or potency assays can be added at each timepoint.
Yes. Our stability studies follow ICH Q1A(R2) guidelines and are conducted with validated, stability-indicating HPLC methods. All raw data, instrument logs, and environmental monitoring records are maintained and can be provided for regulatory submissions to Health Canada.
Yes, lyophilized (freeze-dried) peptides are our most common stability study request. We also offer reconstituted solution stability studies and can design split-study protocols where one portion is stored lyophilized and another as a reconstituted solution.
ICH Q1A(R2)-compliant stability studies with HPLC and MS checkpoints. We maintain your samples and deliver scheduled reports throughout the study duration.
+1 (416) 000-0000 | info@certbiohealth.ca