CMC Pharmaceuticals is a trusted contract testing and drug development laboratory specializing in drug stability testing for API and finished pharmaceutical products. Our services support pharmaceutical companies in determining shelf life, formulation stability, and material compatibility for regulatory compliance and product development. We have a suite of qualified stability storage chambers that are temperature controlled and monitored.
Our team specializes in designing, executing, and interpreting stability studies to ensure the safety, quality, and shelf life of your pharmaceutical product. An advantage to working with CMC Pharma is that we collaborate with you to design stage-appropriate stability protocols. Studies can be executed non-GMP for early stage exploratory studies, or GMP to support regulatory filings. CMC Pharma provides expert stability testing services designed to meet ICH and FDA regulatory requirements at every stage of development.
With expertise in ICH stability studies, custom-designed stability programs, and regulatory-compliant analytical testing, we help pharmaceutical manufacturers de-risk their drug programs and ensure successful tech transfers to commercial manufacturing. We routinely perform real time, in-use, and accelerated stability evaluations including accelerated shelf life studies and photostability studies.
With our integrated regulatory insight and laboratory expertise, we generate the data you need for IND, NDA, ANDA, and global submissions.
Stability studies are essential for understanding how environmental conditions, such as temperature, humidity, and light exposure, affect a drug product’s quality over time. These data determine shelf life, storage conditions, and packaging requirements.
Regulatory authorities require stability programs that demonstrate your product will remain safe and effective throughout its intended lifecycle. CMC Pharma designs protocols aligned with ICH Q1A(R2), Q1E, and Q1D guidelines, giving you confidence in both your data package and your regulatory submissions.
Our stability testing services comply with cGMP standards, FDA regulattions, and ICH guidelines, ensuring high quality, reliable data for regulatory submissions. Depending on your development phase, we design and execute studies to assess the long-term stability, accelearated degradation, and in-use shelf life of your drug product.
In addition to a wide range of custom and routine ICH stability studies to determine shelf life and drug product or API stability, we determine the compatibility of drug product formulations with manufacturing trains (e.g. compounding and holding vessels, processing equipment, transfer lubing, filtration membranes) and container clousers to support drug product tech transfer packages and regulatory submissions. Material compatibility studies are necessary to ensure successful tech tnrasfer to a commercial manufacturing facility.
Stability studies are typically conducted utilizing ICH guidlines, which are standarized methods for testing and evaluating the quality of a pharmaceutical drug product over time and under an array of environmental conditions. These conditions unclude temperature, humidity, and light, which are amongst the most common degradants. By exposing drug products to certain conditions for varying time periods, the results provide evidence on how the quality if affected and help establish shelf life and storage conditions. While stability studies are most often performed utilizing ICH guidelines, there are times when custom-designed studies are more common, including when developing new drug entities, unconventional formulations, highly sensitive APIs, or with complex manufacturing processes. CMC Pharma has experience in designing and executing a wide range of both ICH and custom stability studies.
Accelerated drug stability testing includes exposing the drug product to elevated stress conditions, such as temperature and humidity, to determine the time of degradation. These studies help identify storage conditions and product shelf life. While accelerated stability testing may not accurately predict real-time stability, it provides faster results and helps identify potential stability issues that affect quality, safety, and efficacy.
Real-time stability studies are typically performed as confirmatory studies to evaluate the quality and stability of a product for the duration of its shelf life. For these studies, a product is stored under its recommended or intended storage conditions and its properties are evaluated to ensure product specifications are met at each time interval. Real-time stability testing provides the most accurate prediction of a product’s shelf life but is the most time-consuming because testing must be performed under the full duration of the products shelf life.
In-use stability testing is required for multi-dose drug products. Drug product safety can be compromised after the container-closure is opened or punchered through exposure to environmental factors, including air and light. These studies establish the period in which the product retains its quality and stability once the container is first used or opened. Common tests include pH, microbial counts, potency, and physical attribute testing, including apperance, color, and consistency.
Unlike traditional contract testing labs, CMC Pharma integrates stability and ICH studies with comprehensive formulation, analytical, and regulatory support. This ensures your stability program is not just a data-generating exercise, but a meaningful driver of pharmaceutical development strategy.
We offer feasibility and non-GMP studies in our laboratory, and when formal ICH stability programs are required, we design and execute studies that meet global regulatory standards.
Our goal is to generate reliable, compliant stability data that supports your submissions and accelerates the path from discovery through commercialization.
Phase Appropriate Studies Are Critical To Program Success
Understanding the stability of a pharmaceutical product is critical throughout its development lifecycle–from early drug discovery to commercialization. Stability testing ensures that a drug remains safe, effective, and compliant with regulatory requirements at every stage and coincides with other CMC related activities.
Stability testing starts early in the development lifecycle to help identify optimal drug candidates and degradation mechanisms. Studies continue with ICH-compliant storage conditions to determine appropriate shelf life and formulation stability. The results and formulation optimizations resulted from stability studies play a crucial role in regulatory approval (IND, NDA) and post-market quality assurance.
CMC Pharma’s custom stability programs ensure that your drug product remains stable under various conditions, reducing development risks and facilitating successful regulatory submissions.
Whether you are working on a major drug development program or require a small, one-off stability study, CMC Pharma will provide high-quality results.
Send us a message or give us a call at 440-485-1734
