Pharmaceutical Stability Testing and Storage Studies
Pharmaceutical Stability Storage Solutions to Ensure Product Integrity
Gain the confidence that products will maintain their quality, safety and efficacy throughout their intended shelf life with HMR Labs’ expert pharmaceutical stability testing laboratory and storage solutions.
Our pharmaceutical stability testing service and laboratory is comprehensive and designed to provide you with valuable, outsourced solutions tailored to your exact needs. Whether it’s stability study design, protocol consultancy, or stability storage and pull point management, all are designed to support reliable shelf-life determination.
ICH-Compliant Pharmaceutical Stability Testing Laboratory and Protocol Development
HMR Labs is capable of undertaking ICH pharmaceutical stability testing and developing ICH stability study protocols, ensuring that any approach is designed to determine the product’s shelf life with a high degree of accuracy and precision.
Through scientific project managers, our consultative approach ensures that testing and analysis meet the data demands of shelf-life determination, formulation development, batch release, quality control, storage and packaging requirements and more. Not to mention, removing the risk of distributing compromised products to safeguard patient safety.
Let our lab experts assist you in ensuring the success of your products in the market!

IN HOUSE SCIENTISTS ARE PERSONAL PROJECT MANAGERS

STANDARD AND CUSTOMISABLE STORAGE CONDITIONS AVAILABLE

35+ YEARS OF ICH STABILITY TESTING EXPERIENCE
A Comprehensive Pharmaceutical Stability Testing Laboratory
To ensure optimal market performance, the HMR Labs team commits itself to delivering insightful data analysis and actionable recommendations at every testing phase and beyond.
Each project and partnership is enhanced by reporting that meets the highest industry standards. HMR Labs’ purpose build laboratories house a range of instrumentation and detector types to ensure our equipment is qualified to conduct:
Real Time and Accelerated Studies Performed at our Pharmaceutical Stability Testing Laboratory
HMR Labs work to assist pharmaceutical manufacturers and research organisations to understand the chemical, physical and microbiological attributes of their drug compounds, determining shelf life and degradation pathways.
Our stability testing laboratory strictly adheres to the international regulatory guidelines set by ICH, the FDA and EMA. These data driven insights are gathered and reported to our customers in real time to ensure pharmaceutical products meet all compliance requirements.
In situations where time-to-market is critical, our stability testing laboratory can undertake an accelerated study by exposing drug candidates to elevated temperature and humidity conditions.
Producing valuable stability predictions of long-term exposure even in shorter time frames, predictive analytics can provide more than just rapid results. It can estimate your products behaviour, facilitate accurate projections and plan the future of new, adapted pharmaceuticals with confidence from robust analytical data.

Pharmaceutical Stability Testing: Forced Degradation and Photodegradation Studies
Placing deliberate stress on pharmaceutical products to gather heat, light, oxidation and pH related changes uncovers vulnerabilities in novel drug compounds. HMR Labs can characterise the degradation of pharmaceutical products and use our knowledge of testing protocols and procedures to equip you with proactive stabilisation strategies and maintain shelf life integrity.
Our pharmaceutical stability testing laboratory also facilitates photodegradation studies for those products that exhibit light sensitivity. We have invested in the latest technology to ensure the highest controlled testing environments, helping you quantifiably determine a developmental drug products’ quality and performance whilst subjected to varying conditions including light exposure.

Stability Testing Laboratory: Indicating Method Development
With novel drug candidates entering the market each day, the assay methodologies used to provide accurate and well-understood stability testing results must also continue to expand.
HMR Labs not only performs stability testing, but also develops stability indicating assay methods to accurately detect and quantify the degradation of products. We take into account the unique formulation and manufacturing challenges our customers face and provide a methodology that is a scalable and valuable asset for wider stability testing applications.

Pharmaceutical Stability Storage
Our stability storage solution is expansive and compatible with a range of requirements to ensure the integrity and quality of pharmaceutical products. The state-of-the-art facility is located in Rochdale, UK, providing stability testing services without compromise to factors such as capacity, study length or turnaround times.
Covering a broad spectrum of testing conditions, HMR Labs can run storage studies to meet all standard ICH guidelines and conditions. We also offer specialised testing environments such as refrigeration, frozen and other bespoke conditions when requested.
We work collaboratively to ensure a streamlined process, from study design to execution. HMR Labs delivers the highest industry standards in pharmaceutical stability storage.

Quality Assured, Regulatory Stability Guidance
Creating long term partnerships is our priority. We are dedicated to timely communication, collaborative research, and proactive support throughout project lifecycles; it is vital that regulatory guidance and support is a part of this.
We ensure that our pharmaceutical stability testing laboratory will meet international standards and perform analysis that will enable smooth submissions to regulatory authorities, advance batch release and confirm quality control. Saving you both valuable time and internal resources during your drug development journey.
Partner with HMR Labs for value-add stability testing of pharmaceutical products and gain a competitive edge in the pharmaceutical market.

Use pharmacopeial or customer specific methodologies

PRECISION and reliability in pROTOCOL PREPARATION

Knowledge transfer and project management packages available
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Contact us today to discuss your specific test requirements directly with our team of analytical scientists.
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