A pharmaceutical packaging system is the sum of the packaging components that come into direct contact with the drug and the outer packaging components that work together to contain and protect the active ingredient and dosage form of the drug.
Extractables are compounds that can be extracted from packaging material under controlled experimental conditions. Leachables are a class of extractables that are compounds that actually migrate into the final product during the expected lifetime or exposure time of the final product.
Our Services
Pharmaceutical packaging may include plastic, polymer, rubber and glass material components as well as printed surfaces and coatings. Extractables and leachables are chemical substances that may be released from a product or material that enters or comes into contact with the human body. Alfa Chemistry provides efficient extractables and leachables testing services to ensure that pharmaceutical products do not produce substances that may be hazardous to human health during production, storage and use.
Our Service Process
- Our service starts with gathering all the information about the packaging system of the client's product in order to have a comprehensive understanding of the potential sources of extractables and leachables and to develop a testing strategy accordingly.
- Combining our experience and extensive knowledge of extractables and leachables research, we perform an initial risk assessment of all primary and secondary contact materials of the client's product.
- We simulate the conditions of use and storage of the product and study the chemical stability and release characteristics of the material in different environments.
- We employ a range of advanced analytical instruments to identify organic and inorganic contaminants, including liquid chromatography, gas chromatography and plasma spectroscopy.
- We develop and validate extractables and leachables detection methods, and qualitatively and quantitatively analyze the resulting chemical substances.
- We determine whether the test results meet safety standards in accordance with FDA, USP, ISO and other relevant regulatory and compliance requirements.
- We prepare detailed extractables and leachables test reports for our clients, including extraction conditions, analytical results, safety evaluation and recommended control measures.
Our Solution Features
- Customized testing solutions
Risk assessment of extractables and leachables in the pharmaceutical industry requires consideration of factors such as dosage, frequency of administration and pharmaceutical dosage form. Our extractables and leachables program is specifically designed to assess the risks associated with leaching impurities by tailoring it to the customer's drug product and storage container materials.
Extractables and leachables in pharmaceuticals have become a key area of focus for regulatory agencies worldwide. We conduct extractables and leachables testing in accordance with nationally and internationally recognized standards such as GMP, FDA, and EMA, and our staff is experienced in conducting extractables and leachables studies to ensure that regulatory expectations are met.
At our company, the team includes experts familiar with the review and approval of generic drugs in various regions/countries around the world. We assist determine whether any ingredient that comes into contact with a client's product could negatively affect the product when exposed to stressful conditions or when used regularly over a long period of time.
Contact us to learn more about our extractables and leachables testing services. Our team is ready to help you with your extractables and leachables testing needs to support drug registration and marketing applications and accelerate product commercialization.
