At KamTek, we provide ICH Q1A(R2)-compliant stability storage and testing to ensure your drug products or biologics meet global regulatory requirements. Drug Stability testing is a critical step in the drug development process, evaluating how environmental factors like temperature, humidity, and light impact the potency, safety, and shelf life of pharmaceutical products. We provide complete documentation throughout the study process and facilitate domestic and international shipping at predefined conditions to various labs for additional testing requirements.

 

What is ICH stability storage:

The ICH Stability Testing Guidelines (ICH Q1A(R2)) provide a harmonized framework for assessing the stability of new drug substances and drug products.

 

Stability testing is of three types:

Type

Purpose

Temperature

Humidity

Long-term testing

Evaluates stability under normal storage conditions

25°C ± 2°C

60% RH ± 5% RH

Accelerated testing

Assesses degradation at higher temperatures and humidity

40°C ± 2°C

75% RH ± 5% RH

Intermediate testing

Conducted when long-term and accelerated conditions differ significantly

30°C ± 2°C

65% RH ± 5% RH

 

These tests are conducted with a testing frequency of 0, 3, 6, 9, 12, 18, and 24 months for long-term studies, with more frequent intervals for accelerated studies.

 

Stability tests are typically conducted on at least three primary batches of a drug using the proposed packaging.

KamTek’s Approach to Stability Testing

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:

 

  • Continuous Monitoring: External temperature and humidity probes track conditions 24/7, ensuring data accuracy and compliance.
  • Backup Stability Chambers: In case of equipment failure, backup chambers prevent interruptions in your study.
  • cGMP & ISO Compliance: We rigorously document all incidents, log environmental conditions in real time, and maintain transparent records for client review.
  • Customizable Protocols: Based on study results, we allow refinement and modify testing protocols to meet specific regulatory and product requirements. 

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.

 

KamTek provides stability testing not only for small molecule drug types or drug products, but also for peptides, vaccines, medical devices, biologics etc.

 

We offer stability testing at a range of conditions, including:

  • 250C/60%RH
  • 300C/65%RH
  • 300C/75%RH
  • 400C/75%RH
  •  20C – 80C
  • -200C
  • -800C

 


Why Stability Testing Matters

 

Stability testing is essential for regulatory approval and ensures that drugs maintain their intended efficacy over time. It supports:

 

  • Regulatory submissions: Required for drug clearance in clinical trials and human use.
  • Shelf-life determination: Establishes expiration dates under long-term conditions.
  • Packaging decisions: Helps select the best container-closure system.
  • Product quality assurance: Prevents degradation-related failures in the market.

How Stability Testing Helps in Drug Clearance for Trials

 

 

Regulatory agencies such as the FDA, EMA, and other global authorities require stability data as part of Investigational New Drug (IND) and New Drug Application (NDA) submissions.

Stability studies help demonstrate that a drug remains effective and safe throughout clinical trials, streamlining the approval process.


 

Why Choose KamTek for Your Stability Testing Needs?

 

  • Zero capital requirements - 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.
  • Withdraw Anytime – We understand that project requirements may change, or you need to get back to the drawing board. Our clients have the flexibility to withdraw from the study at any stage, ensuring full control over their research and development efforts.
  • Regulatory & Licensing Compliance – 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. Click here to learn more.
  • Flexible Storage Options – Clients can choose between-Dedicated storage (Reserve an entire chamber for your study), Shared storage (Cost-effective solution for smaller sample quantities).
  • Disaster Recovery & 24/7 Monitoring – Our state-of-the-art 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.
  • End-to-End Solutions – KamTek is your one-stop partner for all associated services related to stability testing, offering secure temperature-controlled short- and long-term storage, shipment logistics, and additional lab testing (microbial and cell culture, assays and other tests) to streamline your workflow.
  • 30+ Years of Expertise in Biorepository Services – With decades of experience in regulated storage and environmental monitoring, we bring unmatched reliability and industry expertise to your stability testing needs.