We have a full Stability Storage and Testing Program at Chromak Research to meet the high standards of the pharmaceutical, chemical, and manufacturing industries. With well over 30 years of experience in the industry as a premier contract testing laboratory, Chromak Research conducts stability testing to establish the shelf life, expiration dating, and best storage conditions for a variety of products such as APIs, OTCs, and finished drug products.
Importance of Stability Testing
Stability testing is an important component of product development and regulatory submission. It evaluates the impact of drug substance or product quality, strength, and purity over a period of time under different conditions of environment such as temperature, humidity, and light. Such studies validate that the product remains safe, effective, and within specifications across its shelf life.
Regulatory agencies worldwide require stability studies and are required for New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and other approvals. Chromak Research performs real-time and accelerated stability studies as per ICH Q1A (R2) guidelines, FDA regulations, and other relevant standards.
Our Stability Storage Capabilities
Chromak Research has a complete suite of stability chambers, which can replicate varying environmental conditions. Our certified chambers are regularly monitored and serviced to present accurate and compliant testing conditions. Our stability storage conditions include:
Top Advantages of Chromak’s Stability Testing Services
Validated Stability Chambers meeting FDA and ICH regulations
Sophisticated stability tracking systems for scheduling and reporting samples
Securely stored retention samples
DEA-registered facility for controlled drug substances
Special storage area with high-security measures
Testing both active pharmaceutical ingredients and finished drug products
We also conduct on-time testing at predetermined intervals as dictated by your stability protocol. Our analysis methods involve assay, impurity profiling, dissolution, microbiological testing, physical characteristics analysis, and others—all conducted by trained professionals with validated methods.
Regulatory Compliance and Data Support
Our stability data has validated many NDAs, ANDAs, and worldwide regulatory filings. We deliver comprehensive documentation such as stability protocols, interim reports, and final study reports to facilitate hassle-free regulatory review.
With our state-of-the-art quality management system, Chromak Research guarantees compliance, data integrity, and complete traceability from the receipt of the sample to the final report.
Partner with Chromak Research
If you’re seeking a proven partner for stability storage, and testing, rely on Chromak Research’s scientific reputation and expertise. From development of a new drug, reformulation of an existing product, to post-approval stability studies, our staff will customize the program to your exact requirements.
Contact Chromak Research today to request a quote or to discuss your stability storage and testing requirements. We’re here to support your compliance, development, and commercialization goals with accuracy, integrity, and speed.
