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Natoli Scientific’s preclinical stability studies represent a critical facet of our pharmaceutical testing services, providing essential data on the shelf life and storage conditions of drug candidates. These studies are expertly designed to evaluate physical, chemical, and microbiological stability, ensuring that formulations retain their safety, efficacy, and quality over time. Our state-of-the-art facilities simulate various environmental conditions to scrutinize the integrity of products under stress-testing scenarios. The results gleaned from our stability studies guide the development of robust drug formulations and packaging, aid in regulatory submissions, and lay the groundwork for successful commercialization.

Preliminary Stability Studies

Natoli Scientific offers preclinical preliminary stability studies as a precursor to formal stability testing. These non-GLP (Good Laboratory Practice) studies provide an early glance at the shelf life and resilience of new drug formulations. Tailored to the client’s needs, preliminary stability studies serve as a cost-effective way to identify potential degradation pathways and optimize formulation components before investing in more extensive GLP studies.

Our formulaic approach allows for rapid turnaround times, feeding critical information back into the development pipeline to modify and improve drug candidates during the early stages of drug discovery and development.

Forced Degradation Studies

Forced degradation studies are fundamental in evaluating the stability of pharmaceutical compounds, and Natoli Scientific prides itself on its rigorous approach to these assessments. Our forced degradation protocols are designed to expose drug substances and products to extreme conditions, such as elevated temperatures, humidity, oxidation, photolysis, and hydrolysis. The goal is to understand how the active ingredients and the final products behave under stress, which helps in predicting their degradation products and pathways.

These studies are not only pivotal for determining the shelf life and storage recommendations but are also a key element of the regulatory submission package. Natoli Scientific’s expertise in conducting these studies assures our clients that they will obtain a comprehensive understanding of their product’s stability profile, thereby maximizing its potential for successful market entry and patient safety.

Accelerated Stability Studies

At Natoli Scientific, our accelerated stability studies are a key offering for rapidly assessing pharmaceutical product stability. These studies subject the drug compounds to increased temperature and humidity conditions to accelerate the rate of degradation. This methodology allows us to predict the product’s shelf life and establish expiry dates with a shorter study duration compared to real-time stability testing.

Our precision-controlled environment chambers are calibrated to generate consistent stress conditions, ensuring that clients receive reliable and reproducible data. Leveraging our accelerated stability studies can expedite the development process and support regulatory filings, ultimately bringing effective pharmaceuticals to market more swiftly and safely.

Beyond Use or Expiration Date

To determine the viability of pharmaceutical products over time, Natoli Scientific provides comprehensive services for establishing beyond-use and expiration dates that are compliant with industry standards. By utilizing our two dedicated ICH stability chambers, which are meticulously humidity and temperature controlled, we can accurately simulate long-term storage conditions to assess the degradation of drugs over an extended period. This approach ensures that the potency, purity, and overall quality of the pharmaceutical does not diminish within the set period.

Our rigorous testing procedures, aligned with current regulatory expectations, are key to defining the beyond-use dates for compounded preparations and expiration dates for manufactured drug products. Our commitment to ensuring that these dates are scientifically justified supports pharmacies and manufacturers in protecting patient safety and maintaining compliance with regulatory requirements.

Make Natoli Scientific Your Preclinical Partner Today

At Natoli Scientific, we understand the intricate challenges of drug development and the importance of rigorous preclinical testing. Our comprehensive suite of stability studies, including forced degradation and accelerated stability, are meticulously designed to ensure your pharmaceutical products are safe, effective, and compliant with industry standards.
When you partner with us, you’re not just obtaining quality testing services; you are also leveraging our expertise to streamline your path from the laboratory to the market. Let us help you mitigate risks and achieve your goals with confidence. For pioneering science matched with unparalleled support, call Natoli Scientific at 636-926-8900 today and take the next step towards innovative healthcare solutions that will leave a lasting impact on lives around the globe.
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Call us +1 636-926-8900