Extractables & leachables testing and analysis is a critical step in maintaining the quality of your drug product. Excite Pharma Services provides expert guidance and contract research services to ensure your successful drug development.
Extractables studies are assessments performed on materials. They are performed to identify substances that a patient may be exposed to.
Leachables studies are an assessment performed on the drug product. Materials that come into direct or indirect contact with a drug or biologic product have the potential to leach substances into the final pharmaceutical product. Substances that may leach can originate from various materials at any point in the pharmaceutical supply chain and throughout the product lifecycle. Constituents that leach from primary packaging into the final product when manufactured and stored under its normal conditions are referred to as leachables. Typically, leachable compounds are found in trace amounts but can have a negative impact on pharmaceutical quality with potential to compromise patient safety. Any component used during drug or biologic manufacture, storage, shipping and administration to the patient can be implicated as a source of extractables and leachables.
Excite Pharma Services utilizes the following analytical techniques for extractables & leachables services:
- ICP-MS, GC-MS, PDA / UV Vis, pH, Ion Chromatography, GC-ECD, multiple extraction techniques
If you have any questions or are interested in more details of our metals analysis capabilities, please contact us.