Following ICH Stability Testing Guidelines (ICH Q1A (R2)), KamTek provides a harmonized framework for assessing the stability of new drug substances and drug products by the following stability tests.
| Test Type | Purpose | Temperature | Humidity | Duration |
|---|---|---|---|---|
| Long-term Testing | Evaluates stability under normal storage conditions | 25°C ± 2°C | 60% RH ± 5% RH | 6-60 months |
| Intermediate Testing | Conducted when long-term and accelerated conditions differ significantly | 30°C ± 2°C | 65% RH ± 5% RH | 6 months |
| Accelerated Testing | Assesses degradation at higher temperatures and humidity | 40°C ± 2°C | 75% RH ± 5% RH | 6 months |
| Refrigerated | Evaluates stability under low but above freezing temperatures | 5°C ± 3°C | N/A | Varies |
| Freezer | Evaluate stability in frozen conditions | -20°C ± 5°C | N/A | Varies |
Stability tests are typically conducted on at least three primary batches of a drug using the proposed packaging.
Stability testing is essential for regulatory approval and ensures that drugs maintain their intended efficacy over time.
Through this service we support:
KamTek provides stability testing not only for small molecule drug types or drug products, but also for peptides, vaccines, medical devices, biologics etc.
Our advanced stability chambers adhere to ICH Q1A (R2)guidelines and are designed to provide precise and reliable environmental control for drug stability studies. We ensure:
As our mission states, our primary goal is to bring success to your drug so that it effectively alleviates pain and improves the well-being of humans and animals.
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We consult with your team to define the appropriate ICH Q1A/Q1B protocol, selecting suitable temperature, humidity, and/or light conditions.
Protocols can follow your internal SOPs or be developed by KamTek.
Products are received, inspected, and logged into our secure system with full chain-of-custody documentation.
Samples are placed in validated stability chambers at required temperature and humidity conditions. A positive and negative control are also placed to validate the process.
Each chamber is continuously logged for temperature, and humidity, with redundancy and alert systems in place.
KamTek can pull and package samples at predefined intervals for analytical testing at your site or ship to third-party labs under controlled conditions.
At the end of the study or in between, we provide
Certificate of ICH Q1B-compliant light exposure
Environmental logs (temperature/humidity)
Sample map and inventory logs
Optional interim reports upon request
Setting up ICH stability storage requires significant capital investment in storage devices, monitoring services, documentation, and dedicated personnel. By outsourcing to KamTek, you eliminate these costs while ensuring compliance.
Our clients have the flexibility to withdraw from the study at any stage, ensuring full control over their R & D efforts.
KamTek meets ICH Q1A(R2), cGMP, and ISO compliance, ensuring that your stability data is globally accepted by regulatory authorities like the FDA, EMA, and other health agencies
Clients can choose between-Dedicated storage (Reserve an entire chamber for your study), Shared storage (Cost-effective solution for smaller sample quantities).
Our facility has oversized backup power generator and stability chambers undergo preventive maintenance with temperature and humidity probe calibrations, and we provide round-the-clock automatic and manual monitoring to prevent disruptions. In case of equipment failure, backup chambers ensure study continuity.
KamTek is your one-stop partner for all associated services related to stability testing, offering secure temperature-controlled storage, shipment logistics, and additional lab testing (microbial and cell culture, assays and other tests) to streamline your workflow.
Partner with KamTek for ICH-compliant stability storage, seamless logistics, and trusted regulatory support.
Let’s safeguard your product's integrity—start your stability study today
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