Support Request Testing
Support Request Testing

    ICH Stability Studies

    Ensure the reliability of your products with state-of-the-art ICH-compliant stability storage solutions at Microbac Laboratories. Supporting your compliance, quality, and regulatory needs with precision and care.

    Chemical Analysis

    Trusted Expertise, Continuous Monitoring, and Accurate Results

    Microbac Laboratories supports The International Council for Harmonization Q1 guidelines for stability studies, offering comprehensive management from protocol writing to storage and testing of samples. Our storage chambers are monitored 24/7/365 for temperature and humidity, with alarms sent to dedicated teams and automatic backup power switchover, ensuring peace of mind for your stability study.

    Inositol

    Our Services Include:

    • Stability Program Management: Let our team handle the setup, monitoring, and reporting of your stability studies.
    • Accelerated Aging Studies: Gain quick insights into product performance over time with customized accelerated testing.
    • Custom Storage Solutions: Tailor conditions to match your product’s specific requirements.
    • Sample Management and Testing: Seamlessly integrate with our analytical and microbiological testing services.
    Transmissible Spongiform Encephalopathy (TSE)-Clearance Study

    Industries We Serve

    • Pharmaceuticals
    • Biopharmaceuticals
    • Medical Devices
    • Consumer Health Products
    • Cosmetics
    test tube

    Experience the Microbac Difference

    Microbac Laboratories combines technical expertise with state-of-the-art facilities to deliver trusted stability storage solutions. Whether you’re conducting long-term studies or need quick-turnaround accelerated aging data, we’re here to help.
    compliance

    Certifications & Compliance

    Microbac Laboratories is fully accredited, adhering to the latest FDA, EMA, and ICH standards.
    conversation

    Get Reliable Stability Storage

    Take the next step in ensuring product stability with a trusted partner.

    Our Testing Process

    Request A Quote

    Request a Quote

    The customer provides sample details, including quantity, pull points, container size, SDS, and testing/shipment requirements.

    Choose a Protocol

    Choose a Protocol

    The customer submits their own protocol or requests Microbac to create one tailored to their study.

    Sample Arrival & Storage

    Sample Arrival & Storage

    Samples receive a unique stability study number and are placed in storage chambers under specified conditions. A pull schedule is created.

    Sample Retrieval & Testing

    Sample Retrieval & Testing

    At scheduled time points, samples are removed from storage and either tested in-house, returned to the client, or sent to a subcontract lab.

    Test Results Reporting

    Test Results Reporting

    Results are sent to the client either directly from Microbac or compiled into a Certificate of Analysis if subcontracted.

    Study Completion

    Study Completion

    Remaining samples are either returned, retained in storage, or disposed of per the client’s instructions.

    Why Choose Microbac for Stability Storage?

    ICH-Compliant Storage

    All storage conditions align with ICH Q1 guidelines to support global regulatory requirements.

    Comprehensive Conditions

    • 25°C/60%
    • 30°C/65%
    • 40°C/75% RH
    • 5°C
    • -20°C
    • -80°C
    • Ambient Storage 15°C – 30°C
    • Photostability
    • Custom Conditions

    Secure and Scalable Solutions

    Our storage chambers are monitored 24/7/365 for temperature and humidity, with alarms sent to dedicated teams and automatic backup power switchover for continuous operation.

    Expert Support

    With decades of experience, our team is ready to guide you through every phase of your stability study, offering protocol-driven studies and protocol writing services tailored to your needs.

    Expansive Capacity

    From small-scale trials to large-scale studies, we have the space and infrastructure to meet your needs.


    Background