Our services enable you to accurately identify and measure any impurities in pharmaceutical products quickly and conveniently.
Pharmaceutical Impurities Testing
What are Pharmaceutical Impurities?
ICH Q3A/Q3B guidance documents define impurities as organic, inorganic, or residual solvents. Organic impurities can develop from degradation or in the chemistry process. Inorganic impurities can come from reagents or catalysts, salts, or excipients. Residual solvents in a drug substance or product may come from any step in a chemistry or manufacturing process. Lastly, any of these may come from packaging, labeling, shipping, or other exposure to external contaminants. As a result, it is critical to monitor, control and characterize impurities in both drug substances and drug products.
Impurity Profiling & Risk Assessment - Averica's Approach
Our unique approach to impurity isolation; allows us to use our scalable separation expertise to isolate significant amounts of unknown chemical impurities.
We design projects to help you gain greater control over your product’s quality, safety, and compliance; all at competitive prices.
Our experienced teams have a proven track record in tackling the most difficult projects with a focus on precision, speed, scalability, accuracy, and reproducibility. We are committed to delivering success for our customers in their critical timeframes.
We execute specialized impurity initiatives to enable us to do the following:
- Isolation of trace components as low as 0.01% of bulk.
- Degradation kinetics—Understand formation, purge, and fate.
- Method development and optimization for mass balance issues.
- Qualified impurity reference standards
Averica: Solutions for your Impurity challenges
Our specialized impurity projects can help save you from expensive trial-and-error with tailored solutions that ensure accuracy and efficiency.
Confirm the structure of impurities or conduct pharmacological or toxicological studies on impurities, using rapid characterization and multiple approaches.
Our E&L services allow us to identify a wide range of potential contaminants in your product.
PFAS Screening
Get the best of both worlds when it comes to testing for PFAS compounds – speed and accuracy.
Nitrosamines Testing
With our timely and accurate results, you can be sure that your products are compliant and meet all applicable regulatory requirements.
Averica can provide you with dependable and easy-to-implement solutions to help you achieve drug development milestones. Let’s talk about how we can make it happen.