Stability Storage Testing

At BioLink Lifesciences, we specialize in providing comprehensive Stability Storage and Stability Testing services to pharmaceutical companies, biotech firms, and research organizations worldwide. Our commitment to scientific excellence, rigorous quality standards, and innovative solutions makes us a trusted partner in drug discovery and development. Let’s delve into the key aspects of our services

Stability Storage

Controlled Environments for Optimal Drug Preservation

Our state-of-the-art stability storage facilities house drug samples in environmentally controlled chambers. Under these precise conditions, trial batches undergo rigorous testing to define their shelf life. We adhere to the guidelines set by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).

Key Features:

Five Climatic Zones

Our stability storage covers all five climatic zones, ensuring comprehensive testing across diverse environmental conditions.

Recommended Testing Conditions

We meticulously follow ICH-recommended conditions, including temperature and relative humidity (RH), to simulate real-world scenarios.

Data-Driven Reporting

Our services provide detailed data on physical, chemical, biopharmaceutical, and microbiological properties. Any changes observed during storage are thoroughly documented.

Ranges of Stability Storage Conditions We Offer:

25°C/60% RH
40°C/75% RH
30°C/60% RH
25°C/40% RH
30°C/65% RH
5°C
30°C/75% RH

Importance of Stability Studies

Stability studies play a critical role in drug registration and commercialization. Here’s why they matter:
  • Efficiency Assessment

These studies evaluate the drug’s integrity and efficiency during storage, helping us understand its behavior over time.

  • Global Supply Assurance

Accurate stability data ensures safe and effective drug distribution worldwide.

  • Quality Assurance

Well-framed stability data supports various phases of drug development, from preclinical research to post-marketing surveillance.

Stability Testing

Unveiling Alterations in Drug Substances

Stability testing is essential for assessing how environmental factors impact drug stability. We offer two types of stability testing:

Real-Time Stability Testing

Samples are stored under actual conditions (e.g., room temperature, humidity) for an extended period

Observations over time provide evidence-based data on changes affecting drug quality.

Accelerated Stability Testing

Samples are subjected to elevated stress conditions (e.g., higher temperature, humidity) to predict long-term stability.

This approach accelerates the assessment process, providing valuable insights.

Ensuring Shelf Life and Safety

Our stability testing services contribute to:

Shelf-Life Determination

By monitoring alterations, we establish the optimal storage duration for each drug.

API Integrity

We verify the stability of active pharmaceutical ingredients (APIs) to maintain product efficacy.

Formulation Competence

Our assay, impurity, dissolution, and water content analyses ensure consistent quality across various formulations.

At BioLink Lifesciences, our passion lies in generating high-quality stability data that fuels drug development. Whether you’re seeking stability storage and/or stability testing, we’re your dedicated partner.